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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 5.2 - INSPECTION PROCEDURES

SUBCHAPTER 5.2 - INSPECTION PROCEDURES
5.2.1 - PRE-INSPECTIONAL ACTIVITIES
5.2.1.1 - Pre-Announcements
5.2.1.1.1 - BASIC PREMISES
5.2.1.1.2 - CRITERIA FOR CONSIDERATION
5.2.1.1.2.1 - Type of Inspection
5.2.1.1.2.2 - Eligibility Criteria
5.2.1.1.3 - PROCEDURES
5.2.1.2 - Personal Safety
5.2.1.2.1 - PREPARATION
5.2.1.2.2 - PHYSICAL RESISTANCE/THREATS/ASSAULTS
5.2.1.3 - FACTS Personal Safety Alert
5.2.1.4 - Personal Safety Plan 
5.2.2 - NOTICE OF INSPECTION
5.2.2.1 - Multiple Date Inspections
5.2.2.2 - Inspection of Vehicles
5.2.2.3 - Follow-Up Inspections by Court Order
5.2.2.4 - Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action
5.2.2.5 - When Evidence of a Criminal Violation is Discovered in the Course of a Regulatory Inspection
5.2.2.6 - Use of Evidence Gathered in the Course of a Criminal Investigation
5.2.2.7 - Use of Evidence Voluntarily Provided to the Agency
5.2.2.8 - Concurrent Administrative, Civil, and Criminal Actions
5.2.2.9 - Working with a Grand Jury
5.2.3 - REPORTS OF OBSERVATIONS
5.2.3.1 - Preparation of Form FDA 483
5.2.3.1.1 - INDIVIDUAL HEADINGS
5.2.3.1.2 - SIGNATURE POLICY
5.2.3.1.3 - DATE ISSUED
5.2.3.1.4 - OBSERVATIONS
5.2.3.1.5 - MEDICAL DEVICE INSPECTIONS
5.2.3.1.6 - CORRECTION OF FDA 483 ERRORS
5.2.3.1.6.1 - Errors Discovered Prior to Leaving the Establishment
5.2.3.1.6.2 - Errors Discovered after Leaving the Establishment
5.2.3.2 - Reportable Observations
5.2.3.2.1 - ADULTERATION OBSERVATIONS
5.2.3.2.2 - OTHER OBSERVATIONS
5.2.3.3 - Non-Reportable Observations
5.2.3.4 - Annotation of the FDA 483
5.2.3.5 - Government Wide Quality Assurance Program (GWQAP)
5.2.3.6 - Distribution of the FDA 483
5.2.3.6.1 - ORIGINAL
5.2.3.6.2 - COPIES
5.2.4 - RECEIPT - FACTORY SAMPLES
5.2.4.1 - Items Requiring Receipt
5.2.4.2 - Items Not Requiring Receipt
5.2.5 - INSPECTION REFUSAL
5.2.5.1 - Refusal of Entry
5.2.5.2 - Refusal to Permit Access to or Copying of Records
5.2.5.3 - Refusal after Serving Warrant
5.2.5.4 - Hostile and Uncooperative Interviewees
5.2.5.4.1 - INDICATORS
5.2.5.4.2 - SAFETY PRECAUTIONS
5.2.5.4.3 - PROCEDURES WHEN THREATENED OR ASSAULTED
5.2.5.4.4 - NOTIFICATION OF FBI AND US ATTORNEY
5.2.6 - INSPECTION WARRANT
5.2.7 - DISCUSSIONS WITH MANAGEMENT
5.2.7.1 - Protection of Privileged Information
5.2.7.2 - Refusals of Requested Information
5.2.8 - CONSUMER COMPLAINTS
5.2.9 - INTERVIEWING CONFIDENTIAL INFORMANTS
5.2.9.1 - How to handle the first contact
5.2.9.1.1 - INTERVIEWING METHODS/TECHNIQUES
5.2.9.1.2 - ESTABLISH MOTIVATION
5.2.9.1.3 - ANONYMITY
5.2.9.2 - Protect the Identity of the Source
5.2.9.2.1 - ACCESS
5.2.9.2.2 - STORAGE REQUIREMENTS
5.2.9.2.3 - DISCLOSURE
5.2.9.2.4 - DESTRUCTION
5.2.10 - ROUTINE BIOSECURITY PROCEDURES FOR VISITS TO FACILITIES HOUSING OR TRANSPORTING DOMESTIC OR WILD ANIMALS
5.2.10.1 - Pre-Inspection Activities
5.2.10.2 - General Inspection Procedures
5.2.10.3 - Special Situation Precautions 

SUBCHAPTER 5.2 - INSPECTION PROCEDURES

 5.2.1 - PRE-INSPECTIONAL ACTIVITIES

Prior to the start of any inspection or investigation, you should conduct a number of activities. These will differ based on whether this is an inspection or an investigation. You should review the establishment's factory jacket (if one exists), and registration and listing (if applicable) information. The purpose of this review is to determine the location of the establishment and obtain an overview of the establishment's operations and products as well as an understanding of their compliance history. You should also review the establishment factory jacket to determine if there were any prior safety issues noted, e.g. documented Investigator safety incidents or whether any specific personal protective equipment is needed prior to the start of the inspection. If there has been a past personal safety incident, you should discuss with your supervisor and de¬velop a Situational Plan prior to the start of the inspection. See IOM 5.2.1.4 – Personal Safety Plan.

Prior to initiating any inspection you should become familiar with the reporting requirements for the specific assignment, as well as the requirements of IOM Subchapter 5.10.

If the inspection or investigation is a directed assignment from a Center, ORA headquarters or another district, read it and attached materials to assure you understand the assignment. If the inspection or investigation is being con­ducted in part or solely as a recall follow-up or complaint, refer to Chapter 7 (Recalls) or Chapter 8 (Investigations) of the IOM for additional guidance.

You should review the applicable FACTS assignment to determine if the Personal Safety Alert indicator is checked for this specific firm. The reason for the Personal Safety Alert should be listed in the Endorsement and should be accompanied by a Memo to the Establishment File Jacket or documented in a prior EIR. See IOM 5.2.1.3 Personal Safety Alert.

You should also review the applicable Compliance Program Guidance Manual(s) prior to the start of your inspection or investigation. ORA's Division of Medical Products and Tobacco Program Operations (DMPTPO)Highlighted to denote updated text has written numerous Inspection Guides to assist you in conducting inspections of various types of estab­lishments, products or processes. You should become familiar with the appropriate guides prior to the start of the inspection and utilize them as needed throughout the in­spection. The Centers have issued numerous guidance documents for industry. These documents are normally posted to the appropriate Center's Internet web site.

Subchapters 5.4-5.9 of the IOM contain additional, pro­gram specific pre-inspectional activities, which you should follow

Imported products cross all program areas and our regu­lation of them does not stop at the border. Determine if there are any "import for export" follow-up assignments and be prepared to cover them during your inspection. See IOM 6.2.3.4 for guidance. Please be alert to imported products whenever you make an inspection. During in­spections of domestic firms, if you encounter imported products that appear adulterated, misbranded, counterfeit, tampered with or otherwise suspect, attempt to fully iden­tify the product and the source of the imported products. Contact your supervisor and Division of Import Operations (DIO)Highlighted to denote updated text if necessary.

 5.2.1.1 - Pre-Announcements

Pre-announcements are mandatory for all medical device inspections in accordance with the criteria and instructions below and some BIMO inspections. In all other program areas, pre-announcements may be made at the discretion of the district. If you are going to visit facilities where livestock (including poultry) or wild animals are housed or processed, review IOM 5.2.10. In general, it may be inappropriate to pre-announce inspections of food establishments, blood banks, source plasma establish­ments and some BIMO inspections, but this too is subject to district discretion. If a district believes pre-announcing an inspection of an establishment will facilitate the inspection process then the procedures below for doing pre-announcements for medical device inspections should be followed. ORA's primary purpose for pre-announcing is to assure the appropriate records and personnel will be available during the inspection. It is not to make an appointment for the inspection. It should not be referred to as an appointment to inspect. When doing a pre-announce­ment, it is important you communicate to the establish­ment the purpose of the inspection and a general idea of the records you may wish to review. If you find neither the appropriate personnel nor records available, note this in your Establishment Inspection Report (EIR). The District may use this data in the future when considering whether this establishment should be eligible for pre-announced inspections.

The following is the general outline for pre-announcement of medical device inspections. You are advising the establishment's management of the date and time you will be arriving at the establishment to conduct the inspection. The establishment has no authority to negotiate this. If you, as the investigator, feel the need to accommodate the establishment's request, be sure there are sound rea­sons for doing so and report them in your inspection report.

 5.2.1.1.1 - BASIC PREMISES

Pre-announcement of inspections is to be applied only to establishments that meet specific criteria. Pre-announce­ment may be considered for establishments that manu­facture both drugs and devices or biologics and devices. The eligibility of an individual establishment for pre-an­nounced inspection is at the discretion of the inspecting office using clearly described criteria. (See Criteria for Consideration) The district does not have the discretion to decide the types of medical device establishments eligible for pre-announcement, but may decide the specific estab­lishments' eligibility because they meet the criteria.

The pre-announcement should generally be no less than 5 calendar days in advance of the inspection. Should a post-ponement be necessary, the decision as to rescheduling rests with the investigator/team, but the new inspection date should not be later than 5 calendar days from the original date. Inspections may be conducted sooner than 5 calendar days if requested by or acceptable to the estab­lishment and if this date is acceptable to the investiga­tor/team.

To participate in the pre-announcement portion of the program, establishments are expected to meet the commitment to have appropriate records and personnel available during the inspection.

Pre-announced inspections will not limit an investigator's authority to conduct the inspection. Inspections will be as thorough as necessary.

 5.2.1.1.2 - CRITERIA FOR CONSIDERATION

When deciding whether an establishment qualifies for a pre-announced inspection, you must consider whether both the type of inspection and the establishment's status meet the following specific criteria.

 5.2.1.1.2.1 - Type of Inspection

Only the following types of inspections are appropriate:

  1. Pre-market inspections (PMA, 510(k))
  2. Foreign inspections
  3. Quality System/Good Manufacturing Practice (QS/GMP) inspections:
    1. Biennial routine inspections
    2. Initial inspections of new facilities or newly registered establishments
    3. Initial inspections under new management and/or ownership.

 5.2.1.1.2.2 - Eligibility Criteria

Establishment's eligible for pre-notification should meet the following requirements:

  1. Non-violative QS/GMP inspection histories (inspections classified as no action indicated (NAI) or voluntary action indicated (VAI)). For VAI, adequate corrections of conditions observed and listed on FDA 483 during the previous inspection were verified and did not lead to any further agency action.
  2. To remain eligible for pre-announced inspections, establishments must have a history of having individuals and/or documents identified in previous pre-announced inspections reasonably available at the time of the inspection.

 5.2.1.1.3 - PROCEDURES

Procedures:

  1. The investigator designated to conduct the inspection will contact the most responsible individual at the facility. You should leave a message requesting a return call if the most responsible person at the facility is unavailable at the time the call is made. The district should use good judgment as to what is a reasonable time frame to await the return call.
  2. Changes in dates should be kept to a minimum. If a change is made, a new date should be provided as soon as possible, which will facilitate the inspection and accommodate the investigator's schedule. The establishment should provide a valid reason for requesting a change in the start date. A valid reason should be the same as you would accept if presented with the information during an unannounced inspection.
  3. Inform the establishment as to the purpose, estimated duration, and the number of agency personnel expected to take part in the inspection. The products or processes to be covered should be described if this will facilitate and be consistent with the objectives of the inspection.
  4. When known, specific records/personnel will be requested at the time the inspection is pre-announced.
  5. The notification should be as specific as reasonably possible and specify the date for the start of the inspection.

Include in your EIR whether or not the inspection was pre-announced and include information on any difficulties experienced in notification or accessing records or personnel, which should have been available as a result of pre-announcing the inspection. For medical device establishment inspections, if not pre-announced, describe briefly in the EIR why not. If an establishment should become ineligible for pre-announcement, the endorsement of the EIR should include this statement. This information will be necessary for making a determination regarding future pre-announced inspections of the establishment. In addition, it is advisable to inform the establishment during the current and subsequent inspections of the action(s), which may have caused them to be ineligible for pre-announcement.

Subchapters 5.4-5.9 of the IOM contain additional, program specific pre-inspectional activities, which you should follow.

 5.2.1.2 - Personal Safety

ORA considers the safety of investigators, inspectors and all those who meet with regulated industry to be of the utmost importance. Personal safety concerns are defined as those factors FDA employees should maintain awareness of which potentially affect their safety during an inspection, such a threatening situation; or where specific personal protective safety equipment is warranted; or where a particular inspection may be medically contraindicated for specific FDA personnel. When these conditions are noted during an inspection, the investigator should discuss the situation with their supervisor and ensure that the Personal Safety Alert is checked in FACTS and a Memo to the File is generated see IOM 5.2.1.3 For information concerning personal protective equipment, see IOM Subchapter 1.5

Physical resistance to FDA inspections and threats to, or assaults on, FDA employees engaged in their work are extremely rare. However, there will be times you are confronted by unfriendly or hostile persons. ORA has offered various conflict resolution training courses to assist and prepare you for how to diffuse a situation. In most instances, conducting your activities with tact, honesty, diplomacy, and persuasiveness will be enough to diffuse the situation. While at times, you may have to adopt a firm posture, you should not resort to threats, intimidation, or strong-arm tactics. Refer to IOM 5.2.5.4 for Hostile and Uncooperative Interviewees.

Safety is the responsibility of all FDA employees, including you, your supervisor and other Agency management. When you receive an assignment, it is important to evaluate the assignment not only in accordance with IOM Section 5.2.1, but also with respect to your personal safety. If you determine there is the possibility of a threat to your personal safety, consult with your supervisor. You and your supervisor should consider developing a Situational Plan in preparation for the inspection.

 5.2.1.2.1 - PREPARATION

Below are some suggested items the District may consider when preparing for your next assignment to assess if there are potential personal safety issues. This list is not meant to be all inclusive.

  1. Does the assignment involve working with other Federal Agencies such as U.S. Marshals, Federal Bureau of Investigations, US Customs in executing search warrants, seizures etc?
  2. Does the assignment involve working with or contacting FDA’s Office of Criminal Investigation?
  3. Does the assignment involve a firm where there is a suspicion and/or knowledge of questionable or illegal activities?
  4. Does the assignment involve a suspected tampering and/or a visit to an individual’s residence?
  5. What is the past history from a personal safety standpoint with the prior interactions with representatives of this firm? Have the FDA’s State counterparts or other Federal and/or local agencies indicated a concern for personal safety? What does the firm’s establishment file indicate about personal safety over the past inspections?
  6. What is the location of the firm or the operation? Is it in an area which may be unsafe? Have the inspected firm or any of it’s employees been uncooperative with government officials?
  7. Is the firm known to the Agency? Has the Agency any additional information which would assist in your evaluation?

If these questions and/or others result in a concern for your personal safety, then a Personal Safety Plan should be developed and approved by district management before conducting the assignment. See IOM 5.2.1.4 - Personal Safety Plan.

Due to the unlimited variability of potential safety situa­tions, it is not feasible to prescribe in the IOM what to do in every instance. The decision of what to do in each individual circumstance rests with the investigator and their district management. Your district management is most familiar with the specific firm in question, the regulated industry, as well as other local Federal, State and Local officials who may be able to provide you additional information and assistance. In addition, the experience of your district management combined with the various training courses on conflict resolution may also be consulted. Districts should notify The Office of Operations (OO) (Gail Katz) to inform headquarters of any potential safety concern, so that personal safety issues may be tracked. OO will also maintain a library of Personal Safety Plans which may also be of use to your District. OO may be contacted at 301-796-0358 or at the following personal safety e-mail address: ORAHQDFICSOSAF@FDA.HHS.GOVHighlighted to denote updated text

 5.2.1.2.2 - PHYSICAL RESISTANCE/THREATS/ASSAULTS

If you receive physical resistance or threats, or if you sense the real possibility of an assault, disengage from the confrontation, get to safety, and call your supervisor immediately. Make careful and exact notes later of who said what to whom, who did what, and whether someone tried or succeeded in threatening, assaulting or taking information or equipment or samples from you. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. Your safety is more important to the United States than the inspection or the sample. FDA will work with law enforcement government officials, e.g., the Federal Protective Service (FPS), FDA's Office of Criminal Investigations' (OCI) Special Agents, local police, or United States Marshals to assist an inspection team if there is a reasonable fear of danger to the investigator.

If you are assaulted (either physically or put in fear by threats of physical violence), your supervisor can summon local police, the Federal Protective Service (1-877-437-7411), United States Marshals, FBI or contact OCI headquarters for assistance (301-294-4030). While OCI does not normally provide physical security in these cases, they will assist in threat evaluation based on specific facts and available criminal databases. OCI can also make contacts with local police and federal agencies based on previous established liaisons. If you have been assaulted or threatened and you are unable to reach your supervisor or other district management, you should contact the local police in the area where the assault or threat occurred. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. Make sure that any inspected facility where weapons are observed, or where threats or assaults occur, is identified on that facility's Endorsement page of the inspection report for that facility and to your supervisor, so that Investigators or Agents who follow you into that facility will be alert to those possibilities. Your supervisor would also be responsible for checking the Personal Safety Alert box in FACTS and for beginning the notification process to alert other Federal or State agencies that also inspect the facility of the possible danger. For more information see IOM 5.2.1.3 Personal Safety Alert. For specific safety guidance related to inspections and interviews, see IOM 5.2.5.4.2 Hostile and Uncooperative Interviewees.

In addition, in any instance where you have perceived a threat to your personal safety during an inspection, investigation or sample collection, you should exit the situation immediately and report it to your supervisor. You should then write a memorandum of the event in a factual manner including information pertaining to the who, what, when, where, and how of the event. Be careful in any descriptions you give or write of such events, just as you are in recording other evidence that may result in a court case. This memo will be filed in the official establishment file jacket and copies be sent to any and all resident posts and import offices who may interact with this firm. The memo will be filed on the opposite side of the folder from all other documents and will be a printed on eye-catching color paper in order for the document to be visible to the next Investigator. The memo should be retained and maintained within the district. A copy of the Memo documenting the personal safety situation should also be sent to Office of Operations, Attn: Gail Katz.Highlighted to denote updated text

 5.2.1.3 - FACTS Personal Safety Alert

Within the Maintain Firms Option in the FACTS system, there is Personal Safety Alert option that allows the supervisor (FACTS Supervisor Role) to check the appropriate box to advise the FDA investigator that there is a personal safety issue. Only the FACTS Supervisor Role will allow for updating the Maintain Firms screen. This personal safety alert may be selected when there is a potential hazard identified:

  1. Where a previous threat/assault or physical resistance occurred
  2. Where specific personal protective equipment is needed (respirators etc)
  3. Where there are specific medical considerations for a population of investigators (e.g. the firm manufactures a drug hazardous to women of child-bearing years or those with allergies to peanuts, penicillin, or other products.)

In any example listed where there is a Personal Safety Alert, the specific safety alert should be documented both in the Endorsement and in a Memo to the File. The memo should be flagged “MEMO TO FILE - PERSONAL SAFE-TY ALERT” and should provide the factual information to support why the investigator should be alerted to the safety issue. Be careful in any descriptions you give or write of such events, just as you are in recording other factual evidence that may result in a court case. The memo should be filed in the official establishment file jacket and copies sent to any and all Resident Posts and Import Offices who may interact with the firm. The memo will be filed on the opposite side of the folder from all other documents and will be a printed on eye-catching color paper in order for the document to be visible to the next Investigator. The memo should be retained and maintained at the District Office. A copy of the Memo documenting the personal safety situation should also be sent to the Office of Operations, Attn: Gail Katz.Highlighted to denote updated text The Supervisor and/or other District management will be responsible for evaluating any corrective actions taken by the firm or individual to remove or stop the potentially dangerous situation or condition. If the situation remains potentially dangerous, the Personal Safety Alert should be maintained in FACTS. Follow-up inspections at the facility should continue to document whether or not the safety situation continues exists. If the situation has been resolved (new management, dismissal of an employee, cessation of penicillin in a facility, etc) the Personal Safety Alert should be removed from FACTS by the supervisor.       

 5.2.1.4 - Personal Safety Plan

A Personal Safety Plan is an investigative tool developed to assist in managing and preparing for a potentially dangerous situation. Districts should consider developing a Personal Safety Plan when the conditions surrounding the specific inspection, investigation or sample collection indicate a plan is needed. The plan allows all those involved to carefully evaluate the specific inspection in order to prepare for a successful conclusion. Utilizing Personal Safety concepts prior to a potentially dangerous situation is part of the training programs of many other Federal Agencies. The plan should document what specific roles and responsibilities are needed to conduct the inspection/investigation of sample collection. The plan should also answer the questions: Who, What, Why, When and Where concerning the potential danger.

There are seven principles to a Personal Safety Plan. These are:

  1. Summary of Potential Hazards: This section of the personal safety plan includes all of the potential hazards, in a detailed description, that prompted the need for a personal safety plan. Be sure to answer the questions: Who, What, Where, When, and Why. Also include any specific hazards that require personal protective equipment or situations at the facility that may cause allergic reactions for investigators or analysts. Include in the section information from past inspection reports, discussions with previous FDA, State or local investigators, as well as any environmental or plant/facility specific information that would negatively impact a successful personal safety plan when initiated.
  2. Sources of Information: This section of the personal safety plan includes all the sources from which your potential hazards were collected. For instance, document which FDA investigator or State inspector supplied factual statements; state the documents or databases from which you obtained information to assist in your hazard summary. This section is important, as it documents factual evidence, similar to all of your other FDA factual inspection gathering information.
  3. Response Alternatives: This section will be the most important part of your plan because it includes all of the details of what will be done to mitigate the hazards. In this section, provide a list of factual, practical responses or options to consider. This will also allow your supervisor to see all the possible ways to handle the situation. The response plan should also outline all of the tools that you possess to assist you in handling the situation carefully, including training, experience, and other procedures you have at your disposal. Roles and responsibilities of all involved in the plan should be identified including those intended to be on-site, and those who will be off-site, and participating in the plan.
  4. Communication: provide all information about how communication will occur between on-site and off-site participants; between those present on-site, and any emergency, law enforcement or medical responders. Also consider types of communication, e.g. code words for emergencies.
  5. Transportation: Provide information in the plan as to how travel to the facility will happen. Is there a coordination point? Do you intend to use Government marked or unmarked cars? Who will ride in each car? What route will be taken going to and leaving the facility? Consider where you will park the car when you arrive at the facility. Consider what modes of communication will be used to communicate if multiple vehicles are used.
  6. Equipment: Include in this section all equipment needed to initiate this plan. Is personal protective equipment needed? Is there any special sampling equipment or other equipment needed? Include in this section, equipment such as communication tools, FDA forms, etc. Assure that the equipment needed is in full functioning mode.
  7. Emergency Exit Strategy: Describe in this section what the exit strategy will be in the event of an emergency. Consider emergency strategies for safety (issues), as well as any medical emergency. How will the emergency be communicated on-site and off-site? How do you exit the facility and return to your vehicle? Is there a scheduled meeting point to assure all are safe? The goal is to have no one left behind. Remember to contact your supervisor when you return to safety.

Once the plan has been completed, a debriefing of the situation should occur with all who were involved in the plan development. Evaluate what went well, what needed improvement, what would be done differently the next time. Evaluate whether the plan was successful and document lessons learned for the next time.

The Personal Safety Plan should be developed by the investigator, supervisor, other investigators who may be familiar with the facility, compliance officer, if needed, and any other individuals (District, Region, or HQ experts, etc.) who may be able to assist in the depth, scope, and specifics of the firm in question. The decision of who should be involved in the development and approval of the plan is left to the districts’ discretion.

District management and all involved in writing the personal safety plan should meet when necessary in order to assure a well developed, and understood personal safety plan. You and your supervisor should maintain contact during the execution of the personal safety plan. The supervisor should contact the employee during these personal safety situations at a predetermined frequency outlined in your plan. A debriefing session should be held following the execution of the plan. Discussions should include what actions worked well and where there are areas of improvement.

For foreign inspections where a Personal Safety Plan is warranted, OOHighlighted to denote updated text will assist the inspection team.  The inspection team’s management may also wish to participate so that there is clear understanding of what actions will be taken for the foreign inspection.

The Personal Safety Plan should be placed in the official establishment file jacket separate from any EIRs in the same location as any Personal Safety Alert memos.  A copy of completed and executed Personal Safety Plans must be sent to OO in order for OOHighlighted to denote updated text to maintain a reference library of all Personal Safety Plans.

 5.2.2 - NOTICE OF INSPECTION

Upon arrival at the firm locate the owner, operator or agent in charge of the establishment. This should be the top Management Official on site. Be certain of this individual's status. Introduce yourself by name, title and organization. Show your credentials to this person and present a properly signed, completed original of the FDA 482, Notice of Inspection.

If additional Agency personnel accompany you during the inspection, they must show their credentials to the top Management Official upon arrival at the site. A new FDA 482, Notice of Inspection must be issued. Submit a true copy of the FDA 482(s) with your EIR. Explain the purpose of your visit. Readily accept any management offer to have a representative accompany you on the inspection.

If non-FDA officials accompany you during your inspection and do not have authority to enter and inspect, you should obtain permission (preferably in advance) from the most responsible individual at the firm. Non-FDA officials and those who do not hold FDA credentials do not sign the FDA 482. See IOM 5.1.1 and 5.10.4.3.3.

For multiple occupancy inspections in drug establish-ments, refer to IOM 5.1.1.11. Inspections of multiple firms, which are separate legal entities, should be reported under separate EIRs.

If faced with a refusal, or partial refusal of inspection, proceed as outlined in IOM 5.2.5.4.

Any time a FDA 482 is issued, also issue FDA 484, Receipt for Samples, if you collect any samples at the firm. See IOM 5.2.4. See IOM 4.1.1.1 and 4.1.1.2 for instructions for issuance of the FDA 482 in certain sampling situations.

See IOM 4.2.4.3 and 4.2.4.4 for situations where you would issue an amended FDA 482 for sample collections only. The FDA 482 may be amended "To Collect Samples Only ".

If you have concerns of when to or when not to issue the FDA 482, discuss with your supervisor.

 5.2.2.1 - Multiple Date Inspections

If your inspection covers more than one day, advise management at the close of each day you have not finished the inspection and when you will return. Do this each day until you finish the inspection. A FDA 482 is not required for each day of an inspection or when different individuals are interviewed. If there will be an extended period of time (i.e., a week or longer) before you can return to the firm to complete the inspection, be sure management is aware of the delay and discuss with your supervisor whether or not you need to issue another FDA 482.

 5.2.2.2 - Inspection of Vehicles

If vehicles are present which are owned or leased by the firm being inspected and it is necessary to inspect the vehicles, the inspection of these is covered by the FDA 482, Notice of Inspection, you issued to the firm.

If vehicles (trucks, trailers, RR cars, etc.) which are not owned or leased by the firm are present and inspection is necessary, a separate FDA 482, Notice of Inspection, is required:

  1. Issue the FDA 482 to the driver of the vehicle.
  2. If the driver is not present and if, after a diligent search, he cannot be located, issue a separate FDA 482 jointly to the firm being inspected and to the firm whose name appears on the cab. Enter the license number of the vehicle on the FDA 482. Give the original FDA 482 to the firm and leave a copy in the cab of the vehicle.
  3. If there is no cab present, prepare a separate FDA 482 modified to read "*** to inspect unattended vehicle ***" and issue it to the firm being inspected as the "agent in charge" of the vehicle. Enter the license number of the vehicle, trailer or RR car number, etc., on the FDA 482. Should the firm being inspected refuse to accept the Notice, leave it in a conspicuous place in the vehicle. Describe the circumstances in your EIR.

 5.2.2.3 - Follow-Up Inspections by Court Order

At times you may be instructed to conduct inspections of firms by authority of an injunction or other court order. This situation provides separate and distinct inspectional authority involving both the authority of the court order and the authority of Section 704 of the FD&C Act [21 U.S.C. 374], each providing independent courses of action.

When assigned to conduct inspections under these situations, obtain a copy of the injunction or other court order bearing the filing stamp and all relevant signatures. Prior to starting the inspection study the order thoroughly for any special instructions of the court. Your supervisor will assist you in determining the depth of the inspection necessary to cover all of the court requirements.

Take a clearly legible copy of the court decree (not necessarily a certified copy) with you to the firm to be inspected.

Present your credentials in the same manner as for any other EI. Issue the FDA 482, Notice of Inspection, modified to read, "Notice of Inspection is hereby given under authority of injunction (provide here the injunction number and/or other identification) against the firm and pursuant to Section 704 ***". Show the person to whom the FDA 482 was issued a copy of the Order, and, read the following statement to that person.

"This inspection is being conducted under the authority of injunction (add the injunction number and/or other identification) (or other court order) granted by the United States District Court against this firm on (date). The inspection will cover all items specified in the decree. In addition to the inspection authority granted in the court decree, I am issuing you a Notice of Inspection under the authority of Section 704 of the Federal Food, Drug and Cosmetic Act which authorizes inspections of firms subject to that Act."

If the firm refuses access to records, facilities, or information for which the decree provides inspectional authority, read the pertinent section(s) or portion of the order to the person refusing so there will be no misunderstanding as to the requirements of the decree. If the person still refuses, report the facts to your supervisor as soon as possible so the court can be promptly advised of the situation. See IOM 5.2.5 for information on handling refusals.

At the conclusion of the inspection, if a FDA 483 is to be issued and you are using Turbo EIR, follow the Turbo instructions to get injunction specific cites on the FDA 483.

When you prepare your EIR, describe the sequence of events in detail including exactly what happened and how you handled the situation. This documentation will help support any charge of violating the court order and/or Section 704 of the FD&C Act [21 U.S.C. 374].

The court order may require a report to the court. Discuss this with your supervisor since the district will normally handle this part of the requirement.

 5.2.2.4 - Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action

You should not issue a Notice of Inspection if the agency is contemplating taking, or is taking, criminal action against a firm without first discussing the matter with your supervisor. District Management will obtain advice from the Office of Chief Counsel and will allow or not allow, the inspection to proceed based on any considerations related to the criminal investigation. Decisions to inspect under such circumstances should be based on considerations of whether or not the request is consistent with FDA's responsibility to assure articles are not produced or distributed in violation of the Federal Food, Drug, and Cosmetic Act or other Federal law within FDA's jurisdiction. The district should ensure these considerations are documented. In no circumstance should an inspection be conducted solely to obtain evidence to support a possible criminal case.

Inspections conducted in accord with this responsibility to protect the public and limited in scope to the authorizing statute are lawful even when criminal action is being considered or pursued. The Fourth Amendment to the United States Constitution prohibits searches without a warrant supported by probable cause. One exception to the warrant requirement includes the inspection of industries long subject to close supervision and inspection, which are conducted under a statute dispenses with the need for a probable cause warrant. Three criteria must be met under this exception from the warrant requirement. First, the regulatory scheme authorizing the regulatory inspection must be supported by a substantial government interest. Second, regulatory inspections must be necessary to further the regulatory scheme. Third, the statute's inspection program, in terms of the certainty and regularity of its application, must provide a constitutionally adequate substitute for a warrant.

Section 704 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374] is appropriately designed to allow regulatory inspections within appropriate limits. This provides the authority to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold, or transport food, drugs, devices, or cosmetics. See IOM 2.2.1.1. FDA's normal inspection procedures provide guidance on what should be considered reasonable under Section 704.

Should the evidence obtained during an inspection become material to a criminal case, it is possible a defendant will claim the use of statutory authority to conduct the inspection was a pretext to conduct an unlawful warrantless search. As long as the limits of Section 704 and normal establishment inspection procedures are followed, the possibility a court will find the inspection to be pretextual should be minimal. Deviations from these limits make it more likely a court would find the use of statutory authority to be pretextual and render the evidence obtained to be inadmissible. Concerns related to the conduct of an inspection while a criminal investigation is being considered or pursued should be discussed with the Office of Chief Counsel.

It is the responsibility of the office generating the inspection assignment to inform the district if a criminal action is ongoing or contemplated. There may be occasions when neither the office generating the inspection assignment nor the District conducting the inspection is aware the Office of Criminal Investigations (OCI) is conducting a criminal investigation of a firm which is subject to regulatory inspection. OCI may determine it is not in the interest of the agency to disclose to other components of FDA the existence of its investigation, as long as OCI is not involved in the agency decision to conduct a regulatory inspection. However, OCI and other components of FDA may also share information as set out below.

 5.2.2.5 - When Evidence of a Criminal Violation is Discovered in the Course of a Regulatory Inspection

There may also be occasions where you are conducting a regulatory inspection at a facility, and, in the course of the inspection, you discover evidence of a criminal violation. If this occurs, you should continue the regulatory inspection as you would under normal circumstances. See IOM 5.2.2.4. Document the observation and notify your supervisor. The district should refer the observations to OCI for their consideration. Evidence of the observation could be used in a criminal investigation, and the evidence could legally be disclosed to criminal investigators.

If you become aware of an ongoing criminal investigation, notify your supervisor. The district should follow the Regulatory Procedures Manual (RPM) and notify the appropriate Center of any OCI involvement in a Center directed inspection.

The discovery of evidence of a criminal violation may also be relevant to FDA's responsibility to assure articles are being produced in conformity with the Food, Drug, and Cosmetic Act. Additional inspections may be warranted. Such inspections should be planned and documented in accordance with the preceding section, "Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action."

 5.2.2.6 - Use of Evidence Gathered in the Course of a Criminal Investigation

The extent to which information gathered in the course of a criminal investigation may be shared with other components of FDA will vary with each case. Investigators should determine the extent of information sharing in accordance with the following guidelines.

Information and evidence gathered in the course of a criminal investigation may be shared with regulatory personnel, subject to two reservations:

  1. Information obtained pursuant to grand jury subpoena or testimony may not be shared. Disclosure of such information to anyone other than individuals identified by the Department of Justice attorney involved could subject the individual making the improper disclosure to sanctions for contempt by the court. Only the court can authorize disclosure beyond these parameters. Information obtained by other means (search warrant, cooperative witnesses, surveillance, etc.) may be shared, subject to the following paragraph.
  2. There may be a need to protect the confidentiality of the criminal investigation. For example, disclosure to regulatory investigators might prematurely disclose the existence of the criminal investigation or the identity of confidential informants. However, whenever you are calculating the need to protect the confidentiality of information gathered in the course of a criminal investigation through means other than the grand jury, you must consider whether it will be in the interest of public health to protect the confidentiality of that information.

Criminal investigators should consult their supervisors to determine whether disclosure should be made to regulatory investigators.

 5.2.2.7 - Use of Evidence Voluntarily Provided to the Agency

Criminal and regulatory investigators may share information and evidence voluntarily provided to FDA, without use of the regulatory inspection authority, search warrant, or subpoena. If criminal investigators decide not to share such information because of a need to protect the confidentiality of the criminal investigation, they should consider the potential impact on the public health of protecting the confidentiality of that information.

 5.2.2.8 - Concurrent Administrative, Civil, and Criminal Actions

It may be appropriate to seek administrative and/or civil remedies against a firm or individual under investigation for criminal violations. There are many issues involved in determining whether such actions may proceed concurrently, or whether certain actions should proceed first. Each situation must be evaluated on an individual basis. If administrative and/or civil remedies are under consideration against a firm or individual also under investigation for criminal violations, representatives from the Center responsible for evaluating the administrative and/or regulatory action should meet with the Office of Criminal Investigations Headquarters staff to discuss issues related to the timing of administrative, civil, and criminal actions. The Office of Criminal Investigations and other components of FDA may share information subject to the reservations set out earlier.

 5.2.2.9 - Working with a Grand Jury

Finally, if you are assigned to work with a grand jury, you should not participate in a regulatory inspection or other regulatory matter involving the same firm or individual(s). Such participation is contrary to long standing agency policy, might be unlawful, and could result in sanctions against the investigator and the agency. You should not participate in any regulatory matters that could result in improper disclosure of grand jury information, even after the grand jury investigation is closed. Grand jury proceedings remain secret even after they are concluded. Under no circumstances should you undertake such participation without first obtaining clearance from the Department of Justice attorney or the Office of Chief Counsel attorney assigned to the grand jury case. See IOM 2.2.7.3 for additional information on Grand Jury proceedings.

 5.2.3 - REPORTS OF OBSERVATIONS

The FORM FDA 483 INSPECTIONAL OBSERVATIONS (see Exhibit 5-5) is intended for use in notifying the inspected establishment’s top management in writing of significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts (see IOM 5.2.3.2) which were observed during the inspection.  These observations are made when in the investigator's "judgment", conditions or practices observed, indicate that any food, drug, device, or cosmetic have been adulterated or are being prepared, packed, or held under conditions whereby they may become adulterated or rendered injurious to health.  The issuance of written inspectional observations is mandated by law and ORA policy.

Be alert for specific guidance in assignments or Compliance Programs which may supplement the following general instructions.

All FDA-483s should adhere to the following general principles:

  1. Observations which are listed should be significant and correlate to regulated products or processes being inspected.
  2. Observations of questionable significance should not be listed on the FDA-483, but will be discussed with the firm’s management so that they understand how uncorrected problems could become a violation.  This discussion will be detailed in the EIR.

All FDA-483s should have the following characteristics to be useful and credible documents: 

  1. Each observation should be clear and specific.
  2. Each should be significant.  Length is not necessarily synonymous with significance.
  3. Observations should not be repetitious.
  4. The observations should be ranked in order of significance.
  5. All copies of the FDA-483 should be legible.

If an observation made during a prior inspection has not been corrected or is a recurring observation, it is appropriate to note this on the FDA 483.

As of 1997, ORA established a FDA 483 annotation policy for medical device inspections. See IOM 5.2.3.4

Regardless of whether an establishment's FDA 483 is annotated, investigators and analysts should make every reasonable effort to discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize surprises, errors, and misunderstandings when the FDA 483 is issued. This discussion should include those observations, which may be written on the FDA 483 and those that will only be discussed with management during the closeout meeting. Industry may use this opportunity to ask questions about the observations, request clarification, and inform the inspection team what corrections have been or will be made during the inspection process. Investigators are encouraged to verify the establishment's completed corrective actions as long as the verification does not unreasonably extend the duration of the inspection.

As of April 2010, ORA established a policy of reporting positive environmental samples on the FDA 483 prior to closeout for food inspections. This policy is applicable only if the results are known before conclusion of the inspection; the investigator should not prolong the inspection to include the results.Highlighted to denote updated text

There may be instances where same day discussion of observations may not be possible due to the volume of documents collected and document review reveals observations on a different day than the documents were collected or in other circumstances. When these instances occur immediately prior to the conclusion of the inspection the lack of a daily discussion of observations does not preclude listing of significant observations which were not previously discussed on the FDA 483.

Turbo EIR

Turbo EIR is an automated FDA 483 and EIR reporting system. Use Turbo EIR to generate the FDA 483 where applicable cite modules exist. Turbo EIR should not be used to create a FDA 483 during an inspection of a firm involving multiple commodity areas when FDA 483 cites do not exist for ALL of the commodity areas for which observations need to be included on the FDA 483. You should be able to write the entire FDA 483 using Turbo EIR.

Use Turbo EIR for all EIRs whether or not your FDA 483 was generated using Turbo and when no FDA 483 was issued. See IOM 5.10.4.

 5.2.3.1 - Preparation of Form FDA 483

It is not necessary to complete all headings of the FDA 483, when multiple page 483s are issued. Complete all headings on the first page and, on subsequent pages, only those necessary to identify the firm and dates inspected. FDA 483s should be issued at the conclusion of the inspection and prior to leaving the premises. However, in preparing some complex FDA 483s, it may be necessary to leave the premises and return at a later time to issue and discuss your inspectional observations. In this case, you should advise the firm’s management your inspection has not been completed and you will return to issue the FDA 483 and discuss inspectional findings. There should be no unreasonable or unwarranted delays in issuing and discussing the FDA 483. During the inspection, do not show the firm’s management a draft, unsigned copy of the FDA 483 or an electronic copy of the FDA 483 on your computer screen. You should issue only a signed FDA 483 at the closeout discussion with management.

 5.2.3.1.1 - INDIVIDUAL HEADINGS

District Office address and phone number - Legibly print the district address. Include the District Office commercial telephone number and area code.

See IOM 1.6.5.1 – Professional Stature for situations where firms express a concern during routine enforcement activities where an FDA 483 was not issued or the activity is not an inspection.

Name and Title of individual to whom report is issued - Enter legal first name, middle initial and last name and full title of the person to whom the form is issued.

Firm name - Enter full, legal name of the firm, including any abbreviations, quotation marks, dashes, commas, etc.

Street address, city, state and Zip Code - Enter street address, city, state and Zip Code. (Not P.O. Box unless P.O. Box is part of the address such as on a Rural Route).

Date(s) of inspection - Enter actual or inclusive date(s) of inspection.

FEI Number - If the FDA Establishment Identifier is on the assignment, enter it here. If not readily available, leave blank.

Type of establishment inspected - Enter the types of the establishment, such as bakery, cannery, wholesale warehouse, drug repackager, salvage warehouse, etc.

Employee(s) signature and Employee(s) name and title - The names of everyone who participated in the inspection with the issuance of a FDA 482 should be listed on the FDA 483 even if they are not available to sign the FDA 483. Each member of an inspection team should sign the FDA 483. However, absence of a team member at the conclusion of an inspection need not prevent issuance of the FDA 483. See IOM 5.1.2.5.1. If you use an electronically generated FDA 483, assure you have a copy for the District files -- an unsigned photocopy or printed duplicate is unacceptable. See IOM 5.2.3.6.2

 5.2.3.1.2 - SIGNATURE POLICY

Everyone present at issuance signs the first and last pages of the FDA 483 and initials each intervening page in the signature block.   

Note: If you are not using the official multi-part FDA 483 form and a copier is not available, insert carbon paper to reproduce a signed copy of the FDA 483.

See IOM 5.2.3.6 - Distribution of the FDA 483.

 5.2.3.1.3 - DATE ISSUED

Enter the date the form is actually issued to the firm’s management.

 5.2.3.1.4 - OBSERVATIONS

“During an inspection of your firm (I) (We) observed” - Where applicable, when formulating each FDA 483 observation, answer Who (using titles or initials when necessary), What, When, Where, How, and challenge each observation by asking So What? (regarding its significance)

Enter your reportable observations succinctly and clearly.  Conditions listed should be significant and relate to an observed or potential problem with the facility, equipment, processes, controls, products, employee practices, or records. “Potential problems” should have a reasonable likelihood of occurring based upon observed conditions or events. Do not cite deviations from policy or guidance documents on your FDA 483.

As appropriate, FDA 483 observations should include relationship of observations to a given population, for example, “Two out of 50 records examined were * * *” or “4 out of 12 bags examined were ***.” When appropriate, a FDA 483 observation may refer to inadequate situations as long as you provide supporting facts (examples) or explanation as to why the condition, practice or procedure observed is inadequate.

It is preferred not to identify individuals or firms by name i.e., suppliers and consignees within the FDA 483.  Where appropriate to support the FDA 483 observation, identify the individual(s) or firm(s) by substituting other non-specific identifying information as below. Document your evidence in your EIR, fully explaining the relationship(s).

  1. The lot number for a component received from or shipped to firm “A”.
  2. The invoice number for a shipment from or to firm “A”.
  3. A patient #, record #.  See IOM 5.2.3.3 item 7.
  4. The study number for a particular Clinical Investigator site.
  5. Other necessary but non-specific identifying information to show the observation’s relationship to a particular firm and/or individual.

Presently there are three ways to issue a FDA 483.

  1. Turbo EIR Field Agent
  2. Traditional hard copy FDA 483
  3. Electronic (non-turbo EIR) version of the FDA 483.

When using a traditional hard copy FDA 483 or electronic (non-turbo) version of the FDA 483, the current version of the 483 must be used.  As of the printing of the 2013 IOM, the current version of the FDA 483 is dated 9/08.

 5.2.3.1.5 - MEDICAL DEVICE INSPECTIONS

The following language should be inserted on the FDA 483 in addition to the above statement: “The observations noted in this form FDA 483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self audits to identify and correct any and all violations of the quality system requirements.”

 5.2.3.1.6 - CORRECTION OF FDA 483 ERRORS

These procedures do not pertain to adverse conditions noted and then corrected during the inspection. Observations of this type stand and should remain on the FDA 483. 

The Inspectional Observations (FDA 483) is of critical importance to both the Agency and regulated industry. Individual FDA 483s may become public through publishing in industry trade press, FOI inquiries, Headquarters postings and other means.  Therefore, complete and accurate documentation of corrections to this official document is critical.

 5.2.3.1.6.1 - Errors Discovered Prior to Leaving the Establishment

Non-Turbo, FDA 483s:

  1. Make handwritten changes to correct the error/s on the original FDA 483 and initial the changes.  Correct errors by striking through the erroneous text and entering the correct information (if any). When possible retrieve and destroy all uncorrected copies of the FDA 483 either provided to or produced by the establishment.
  2. If the establishment has photocopying equipment available and will provide you with a copy of the corrected original FDA 483 then obtain a copy of the corrected original document from the establishment. If the establishment has no such equipment or refuses to provide you with you a copy of the original corrected FDA 483 then make the corrections and initial the changes using carbon paper and retain the carbon copy of the corrected FDA 483 for your District's official establishment file.

Turbo FDA 483s - All corrections/deletions should be made in Turbo.

  1. Changes made to correct errors in the text of the observation will show on the face of the final printed FDA 483. Changed Text deletions will remain visible as strike through and correction made. For example, “lot 1234 5678” – (select text, right click, select font and select strike-through) or from “lot 1234” to “lots 1234 and 5678” and bold the changes “lots 1234 and 5678
  2. If an entire observation is removed, incidental text will be used to add the statement "An observation concerning *** was removed based on discussion with management." 
  3. Addition of a new item

 5.2.3.1.6.2 - Errors Discovered after Leaving the Establishment

Normally, you should not use addenda/amendments to issue additional FDA 483 items after the inspection has been closed out and you have left the premises.  

  1. Non-Turbo, FDA 483s: Discuss any errors with your supervisor. If necessary a revised FDA 483 will be prepared.
  2. Turbo FDA 483s: Discuss any errors with your supervisor. Make all corrections/deletions in Turbo. Changes made to correct errors in the text of the observation will show on the face of the final printed FDA 483.  Changed Text deletions will remain visible as strike through and additions added.
  3. Issuing FDA 483s: Personally deliver the revised and/or corrected FDA 483 addendum/amendment to the firm for discussion. If personal delivery is not practical, mail the addendum/amendment to the firm with a full explanation cover letter. Include a copy of the original FDA 483, and a copy of the letter in the EIR. In addition, you should call the person to whom the original FDA 483 was issued, to discuss the change(s). Document your discussion in your EIR.
NOTE: The issuance of an amended FDA 483 in person or via mail does not change the inspectional end date.  The inspectional end date remains as the date the original FDA 483 was issued.Highlighted to denote updated text

 

 5.2.3.2 - Reportable Observations

You should cite factual observations of significant deviations from the FD&C Act [21 U.S.C. 301], PHS Act, 21 CFR, and other acts where FDA has enforcement authority unless these cites require concurrence or are specifically prohibited – see IOM 5.2.3.3 Non-Reportable Observations.  Examples of these observations generally fall into two categories.

 5.2.3.2.1 - ADULTERATION OBSERVATIONS

Review Sections 402, 501, 505(k), 601, and 704 of the FD&C Act [21 U.S.C. 342, 351, 355(k), 361, and 374]. Include specific factual observations of:

  1. Foods, drugs, devices, or cosmetics consisting in whole or in part of filthy, putrid, or decomposed substances.
  2. Undesirable conditions or practices, bearing on filth or decomposition, which may reasonably result in the food, drug, device, or cosmetic becoming contaminated with filth.
  3. Insanitary conditions or practices which may reasonably render the food, drug, device, or cosmetic injurious to health.
  4. Careless handling of rodenticides or pesticides.
  5. Results of field tests (organoleptic examination of fish, crackout of nuts, etc.) if the results revealed adulteration.
  6. Observations of faulty manufacturing, processing, packaging, or holding, of food, drug, or device products as related to current good manufacturing practice regulations including inadequate or faulty record keeping.
  7. Observations of faulty can closures and/or deviations from recommended processing times and temperatures.
  8. Deviations from the animal proteins prohibited in ruminant feeds requirements (21 CFR 589.2000).
  9. Results of analytical laboratory findings which reveal adulteration.

 5.2.3.2.2 - OTHER OBSERVATIONS

You may include other factual observations of significant deviations from the FD&C Act [21 U.S.C. 301], 21 CFR, Government Wide Quality Assurance Program (GWQAP) requirements, and other Acts as directed by CPs and other agency directives. In some cases, you may cite labeling deviations as directed below. This list is not all inclusive.

  1. Observations indicating non-conformity with commitments made in a New Drug Application, New Animal Drug Application, or in an antibiotic certification or certification exemption form. See Section 505 FD&C Act, [21 U.S.C. 355].
  2. Observations, forming the basis for product non-acceptance under the Government Wide Quality Assurance Program (GWQAP). See IOM 5.2.3.5.
  3. Deviations from blood and blood products labeling requirements as specified in 21 CFR 606.121 and 21 CFR 640.
  4. Animal protein products, and feeds containing such products, that are not in compliance with the labeling requirements of paragraphs (c) through (f) of 21 CFR 589.2000. See Section 403(a)(1) or 403(f) of the FD&C Act [21 U.S.C. 343(a)(1) or 343(f)].
  5. Deviations from the applicable labeling regulations for human cells, tissue, and cellular and tissue-based products (HCT/Ps) as specified in 21 CFR 1271 and CP 7341.002.
  6. Observations indicating drug misuse, failure to maintain proper drug use records, and/or poor animal husbandry practices during tissue residue investigations. See the applicable Compliance Program(s) for guidance.
  7. Observations indicating non-conformity with the postmarketing adverse drug experience reporting requirements as specified in 21 CFR 310.305, 314.80, 314.98, 314.540, or 600.80 or other postmarketing requirements as specified in 21 CFR 314.81 or 600.14.   See Sections 505 and 760 of the FD&C Act [21 U.S.C. 355(k) and 379aa].
  8. Observations indicating non-conformity with the Medical Device Reporting requirements as specified in 21 CFR 803 {See Section 519(a) of the FD&C Act [21 U.S.C. 360i]}; the Medical Devices Reports of Corrections and Removals requirements as specified in 21 CFR 806  {See Section 519(f) of the FD&C Act [21 U.S.C. 360i(f)]}; and the Medical Device Tracking requirements as specified in 21 CFR 821 {See Section 519(e) of the FD&C Act [21 U.S.C. 360i(e)]}.
  9. Observations indicating noncompliance with medical device pre-market notification requirements and pre-market approval requirement under FD&C Act sections 510(k) and 515 [21 U.S.C. 360 (k) and 360e] respectively, should only be made with the prior confirmation of CDRH and/or CBER.
  10. 21 CFR PART 200.10 does allow reporting observations noted at a contract facility to the contracting facility. Before doing this, check with your supervisor to determine if this is appropriate.
  11. Observations indicating non-compliance with LACF/Acidified food registration and failure to file scheduled processes. Before doing this, verify lack of such, as covered in CP 7303.803A.

 5.2.3.3 - Non-Reportable Observations

Do not report opinions, conclusions, or characterize conditions as "violative." The determination of whether any condition is violative is an agency decision made after considering all circumstances, facts and evidence. See IOM 5.2.7 involving discussions with management at which time opinions may be discussed.

Do not quote Regulations (e.g., specific CFR sections) when listing items.

Do not report observations pertaining to:

  1. Label and labeling content, except per IOM 5.2.3.2.2, items 2, 3, 4 and 5 above.
  2. Promotional materials.
  3. The classification of a cosmetic or device as a drug.
  4. The classification of a drug as a new drug.
  5. Non-conformance with the New Drug Regulations, 21 CFR 312.1 (New Drugs for Investigational Use in Human Beings: Exemptions from Section 505(a)) unless instructed by the particular program or assignment.
  6. The lack of registration required by Section 415 and 510 of the FD&C Act. The lack of registration per 21 CFR 1271 Subpart B Procedures for Registration and Listing, promulgated under Section 361 of the PHS Act.
  7. Patient names, donor names, etc. If such identification is necessary, use initials, code numbers, record numbers, etc.
  8. Corrective actions. Specific actions taken by the firm in response to observations noted on the FDA 483 or during the inspection are not listed on the FDA 483, but are reported in the EIR. Except as described in IOM 5.2.3.4.
  9. The use of an unsafe food additive or color additive in a food product.

Use Turbo EIR to document in the “General Discussion with Management” section Non-Reportable Observations, which you discussed with management.  These objectionable conditions fall into three basic categories:

  1. Observations of significant deviations from specific Laws and/or regulations, non-reportable items 1-9 above.
  2. Observations of deviations from specific Laws and/or regulations, which in your judgment, are of “questionable significance” and “deemed not to merit inclusion on the FDA 483,” but do warrant discussion with management.
  3. Observations which in your judgment deviate from official published guidance, not regulations, but warrant discussion with management.

The reporting of observations in these 3 categories is as follows:

Category 1: You should select the appropriate Turbo cite, verify or set the “Print type” to “Do Not Print,” and save the observation in the Turbo database.  This should be done even if there are no other reportable observations.  For example, Lack of Food Registration as covered in IOM 5.4.1.5.3 is not reportable.

Category 2 or 3: You should always report these two categories of observations which were discussed with management under the “General Discussion with Management” heading in the EIR as specified by IOM 5.10.4.3.15. You have options in choosing how observations in category 2 are reported. You may select the appropriate cite in Turbo, enter the “specifically” text regarding the observation, and discussion with management, set it to “Do not print”, save, and it will be automatically entered into the Turbo EIR when it is generated. 

The second option which is also true for category 3 (i.e., there are no Turbo cites for official guidance, only regulations) is the observation/s discussed with management may be entered directly into the Turbo EIR under the “General Discussion with Management.”

 5.2.3.4 - Annotation of the FDA 483

Offer to annotate the FDA 483 for all medical device inspections. The district has discretion to annotate the FDA 483s in other program areas. BIMO inspections are generally excluded from annotations. Annotations of FDA 483s for inspections in other program areas may be done if both the establishment and the investigator/team believe annotation will facilitate the inspection process. When a FDA 483 is annotated it should be done in accordance with the guidance that follows.

Inform the establishment of the annotation program at some point prior to the final discussion with management. Determine from management whether they wish to have their FDA 483 observations annotated. It is voluntary on the part of the establishment. If the establishment does not want one or more observations annotated, you must honor the request.

The actual annotation of the FDA 483 should occur during the final discussion with management. The annotations are succinct comments about the status of the FDA 483 item. It is not permissible to pre-print or pre-format the annotations onto the FDA 483 form. The annotations can be made after each observation, at the end of each page of the FDA 483 or at the bottom of the last page of the FDA 483 prior to the investigator's signature. The establishment should review the annotations on the issued FDA 483 to ensure there are no misunderstandings about promised corrective actions. See  IOM 5.2.3 for discussions of FDA 483 observations with management.

If the establishment has promised and/or completed a corrective action to an FDA 483 observation prior to the completion of the inspection, the FDA 483 should be annotated with one or more of the following comments, as appropriate:

  1. Reported corrected, not verified.
  2. Corrected and verified.
  3. Promised to correct.
  4. Under consideration.

The term "verified" means "to confirm; to establish the truth or accuracy". In this case, you must do the verification. In some situations, you will not be able to verify the corrective action unless there is further district or Center review or until there is another inspection of the establishment. 

The establishment's stated objections to any given observation or to the FDA 483, as a whole should not be annotated on the FDA 483. If they would prefer no annotation, do not annotate it. The EIR should include the establishment's objections to the observation and the fact the establishment declined to have the observation annotated.

When an establishment has promised corrections and furnishes a date or timeframe (without a specific date) for completion, then you may add "by xxx date" or "within xxxx days or months" in the annotation. Where the investigator and the establishment have "agreed to disagree" about the validity of an observation, you may annotate this observation with "Under consideration" or with no annotation based on the establishment's desire.

All corrective actions taken by the establishment and verified by FDA should be discussed in detail in the Establishment Inspection Report (EIR) and reported using the Compliance Achievement Reporting Systems (CARS).

 5.2.3.5 - Government Wide Quality Assurance Program (GWQAP)

When performing product acceptance examinations under the GWQAP, you must discuss all deficiencies with management and report these deficiencies in writing on the FDA 483. This includes all deficiencies related to the FD&C Act as well as deficiencies in complying with contract requirements, which result in non-acceptance. There must be a clear differentiation on the FDA 483 between these two types of deficiencies.

Enter the FD&C type deficiencies (GMP deviations, etc.) first on the FDA 483. If there are deficiencies in contract provisions, draw a line across the sheet and add a heading "The Following Additional Contract Non-Conformances Were Observed." Enter each deficiency, which forms a basis for non-acceptance, followed by the reference to the applicable contract requirement or specification.

 5.2.3.6 - Distribution of the FDA 483

Be sure all copies of the original FDA 483 are legible and distribute as follows.

 5.2.3.6.1 - ORIGINAL

The FDA 483 issued to the firm signed in pen and ink.

Before leaving the premises at the end of the EI present the original to the individual who received the FDA 482, Notice of Inspection, if the person is present and qualifies as "most responsible." If the person is not available or is outranked by someone else, present it to the individual who meets the definition of owner, operator, or agent in charge.

 5.2.3.6.2 - COPIES

Replicas of the "original".

Attach one copy of all FDA 483s issued to the firm to the EIR. This includes turbo or non-turbo copies of any signed, modified, and/or amended FDA 483, or 483 addenda. See IOM 5.2.3.1.6 (Correction of FDA 483 Errors). A copy may be sent to the top management of the firm including foreign management, unless the individual to whom you gave the original is the top official of the firm.

If the inspection covered vehicles as described in IOM 5.2.2.2, leave an exact copy of the list of observations with the firm being inspected. The original will be sent by your district to the firm owning or leasing the vehicle. You must make every effort to obtain the name and address of the vehicle owner. Usually the firm name is on the vehicle; however, it may require a trace of the vehicle license number. Discuss with your supervisor before taking this step. See IOM 4.4.7.2.

 5.2.4 - RECEIPT - FACTORY SAMPLES

You must issue an FDA 484, Receipt for Samples, if you collect any physical sample during an inspection. At the end of the EI and prior to leaving the premises, issue the original FDA 484 to the same individual who received the FDA 482. (See IOM 4.2.5) If this person is not available, give it to someone else who meets the definition of owner, operator, or agent in charge. Submit an exact copy with the EIR. Do not comment on type of examination expected or promise a report of analysis.

 5.2.4.1 - Items Requiring Receipt

Issue a FDA 484 for any item of food, drug, device, or cosmetic actually removed from the establishment.

NOTE: A receipt must always be issued to anyone from whom you obtain Rx drugs. This includes individuals as well as firms. See IOM 4.2.5.4 and IOM 4.4.10.3.44.

The following are examples of exhibit materials also requiring a Receipt for Samples:

  1. Air filter pads,
  2. Rodent pellets, and
  3. Any other physical evidence actually removed from the plant.

 5.2.4.2 - Items Not Requiring Receipt

Do not issue a FDA 484 for:

  1. Items or materials examined during the inspection but not removed from the establishment (report adverse results of analysis of materials on FDA 483 as indicated in IOM 5.2.3.2),
  2. Labels or promotional material,
  3. Photographs taken during the inspection, or
  4. Record(s): including production, quality control, shipping and interstate records.

Firm management may request copies of documents or records you obtain from their firm. There is no objection to supplying them.

See IOM 5.3.8.5 for procedures when a firm requests a receipt for records copied during an inspection or investigation.

 5.2.5 - INSPECTION REFUSAL

Refusal as used in your IOM means refusing to permit an inspection or prohibiting you from obtaining information to which FDA is entitled under the law. See IOM 4.2.3 for information regarding refusal to permit sampling.

In the case of a refusal you must show your conduct was reasonable, fair, and you exercised reasonable precaution to avoid refusal. You must have shown your credentials and given the responsible individual a properly prepared and signed Notice of Inspection, FDA 482.

Inspection refusals may take several forms. All refusals to permit inspection must be reported in your EIR under the "Refusals" heading.

 5.2.5.1 - Refusal of Entry

When you are faced with a refusal of entry, call the person's attention to the pertinent sections of the Acts (Sections 301(f) and 704 of the FD&C Act [21 U.S.C. 331 (f) and 374] and Section 351(c), 360A(a), (b) and (f); 360B(a); and 361(a) of the Public Health Service Act. Portions of these are listed on the front and back of the FDA 482. If entry is still refused, leave the completed FDA 482, leave the premises and telephone your supervisor immediately for instructions.

 5.2.5.2 - Refusal to Permit Access to or Copying of Records

If management objects to the manner of the inspection or coverage of specific areas or processes, do not argue the matter but proceed with the inspection. However, if management refuses to permit access to or copying of any record which you are entitled under law, call attention to Section 301(e) of the FD&C Act [21 U.S.C. 331] or applicable sections of the PHS Act. If management still refuses, proceed with the inspection until finished. It is not an inspection "refusal" when management refuses to provide formula information, lists of shipments, codes, etc., except where specifically required by the law. If the refusal is such you cannot conduct a satisfactory inspection, discuss with your supervisor if a Warrant for Inspection should be requested.

 5.2.5.3 - Refusal after Serving Warrant

If you have been refused entry, obtained a warrant, tried to serve or execute it and are refused entry under the warrant, inform the person, the warrant is a court order and such refusal may constitute contempt of court. If the warrant is not then immediately honored (entry and inspection permitted), leave the premises and promptly telephone the facts to your supervisor.

If you have served the warrant and during the inspection you encounter partial refusal or resistance in obtaining access to anything FDA is authorized to inspect by the warrant, inform the firm that aspect of the inspection is part of a court order and refusal may constitute contempt of court. If the warrant is not then immediately honored, leave the premises and promptly telephone the facts to your supervisor.

 5.2.5.4 - Hostile and Uncooperative Interviewees

More often than not, investigations or inspections are conducted in a reasonable atmosphere. Nonetheless, there will be times you are confronted by unfriendly or hostile persons.

Your activities must always be conducted with tact, honesty, diplomacy, and persuasiveness. Even though you must at times adopt a firm posture, do not resort to threats, intimidation, or strong-arm tactics.

Many times a hostile or uncooperative attitude on the part of individuals being interviewed results from fear, timidity, or previously distasteful encounters with law enforcement personnel. In most cases a calm, patient, understanding and persuasive attitude on your part will overcome the person's reluctance or hostility. Often the mere fact you patiently listen while individuals share their views will make them receptive to your quest.

 5.2.5.4.1 - INDICATORS

Normally you have no way to predict the nature of the individuals you meet. However, there are often indicators, which can alert you, such as:

  1. Establishment inspection reports, endorsements or memorandums may show situations where investigators encountered belligerent or hostile individuals. These reports may be FDA reports and/or State contract reports, if available.
  2. Discussions and conversations with FDA, federal, state and local inspectors and investigators may reveal instances where uncooperative individuals and problem situations were encountered.
  3. The nature of the assignment, program or information requested may indicate some degree of caution is needed.
  4. A firm located in an area with a reputation for unfriendliness to law enforcement personnel should alert you some employees of the firm may be less than cooperative during the investigation.

If you find yourself in a situation which, in your judgment, indicates violence is imminent, stop the operation and make an exit as soon as possible. Immediately report the facts to your supervisor.

 5.2.5.4.2 - SAFETY PRECAUTIONS

The FDA recognizes there are situations where it is advisable to take precautions for your personal safety. In those, consult your supervisor. Some procedures, which may be utilized to minimize the danger, include:

  1. Inspections or investigations carried out by a team of two or more persons.
  2. Consider whether or not the use of an unmarked government car would be more beneficial to assist you in your inspection in lieu of a marked government car.
  3. Request additional information from your State and/or Local Agencies who also regulate and inspect the facilities in question. In many instances, your State counterparts may have more information regarding the facility. This may be especially helpful for those firms that FDA has not yet inspected but were inspected by your State counterparts.
  4. Each government car or inspection team should be assigned one FDA cell phone or alternate communication device. While we recognize that some Investigators carry a personal cell phone, FDA strongly suggests that your personal cell phone not be utilized to contact the firm or firm’s management. In some instances, such uses in the past have resulted in later inappropriate contacts from the firm to the individual FDA Investigator.
  5. Request assistance from local law enforcement agencies prior to or during investigations. This assistance may include information about the facility you are to inspect, assistance with communication devices, or police protection, if the police jurisdiction allows for such an action.
  6. In potentially hazardous investigations such as methadone or schedule II Class Drugs, two investigators may be used and personnel from the U.S. Drug Enforcement Administration, State, or local law enforcement agencies may be requested to accompany you.

 5.2.5.4.3 - PROCEDURES WHEN THREATENED OR ASSAULTED

In instances when you are actually assaulted or threatened, you should immediately notify your supervisor. Your supervisor can summon local police, United States Marshals, or contact OCI headquarters for assistance (301-294-4030). OCI can make contacts with local police and federal agencies based on previous liaison. Also, the District should notify the Office of Operations via e-mail mailto:ORAHQ CSO SAFETY@FDA.HHS.GOV.Highlighted to denote updated text

If you are physically attacked, you have the same recourse as any other citizen as well as the benefit of federal laws protecting government officials while in the performance of their official duties. If you are physically attacked, you should get to safety, call your supervisor, report the incident and seek medical attention if needed. Remember that the medical attention you receive may be used as documentation for the Agency in support of any legal action taken against the firm or the individual.

 5.2.5.4.4 - NOTIFICATION OF FBI AND US ATTORNEY

It is a federal crime for anyone to kill, assault, resist, oppose, impede, intimidate, or interfere with, a federal official in the performance of their official duties.

In case of assault or threat against you, notify your supervisor immediately, so the facts can be submitted to the Federal Bureau of Investigations and the U.S. Attorney's office for immediate action.

The referenced sections in Title 18 of the U.S. Code are:

1. Title 18 U.S.C.A. Section 111 disclaimer icon , which provides:

"111. Assaulting, resisting, or impeding certain officers or employees.

Whoever forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person designated in Section 1114 of this title while engaged in or on account of the performance of his official duties, shall be fined not more than $5,000 or imprisoned not more than three years, or both.

Whoever, in the commission of any such acts uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. **** ".

2. Title 18 U.S.C.A. Section 1114 disclaimer icon , which provides:

"1114. Protection of officers and employees of the United States.

Whoever kills ***** or any officer or employee of the Department of Health and Human Services or of the Department of Labor assigned to perform investigative, inspection, or law enforcement functions while engaged in the performance of his official duties, shall be punished as provided under sections 1111 disclaimer icon and 1112 disclaimer icon of this title. ****".

See Title 18 of the US Code Sections 111 and 1114 for the complete text. See also IOM 1.5.

 5.2.6 - INSPECTION WARRANT

A refusal to permit inspection invokes a criminal provision of section 301(f) of the FD&C Act [21 U.S.C. 331(f)]. Depending on the individual situation, instances of refusal may be met by judicious use of inspection warrants.

Instructions for obtaining warrants are contained in the Regulatory Procedures Manual, Chapter 6-3. See your supervisor for information and instructions.

You are operating as an agent of the court when you serve an inspection warrant and it must be executed expeditiously once served. See IOM 5.2.5.3 for guidance on how to handle any refusal after obtaining a warrant.

In situations where a potential problem is anticipated with the service of a warrant, the District should consider sending a Supervisory Consumer Safety Officer or Compliance Officer and a U.S. Marshal with the Investigator to assist and supervise the serving of the warrant.

After obtaining an Inspection Warrant, return to the firm and:

  1. Show your credentials to the owner, operator, or agent in charge,
  2. Issue the person a written Notice of Inspection (FDA 482),
  3. Show that individual the original signed Inspection Warrant,
  4. Give him/her a copy (not the original) of the warrant.

The copy you provide need not be signed by the issuing judge, but the judge's name should be typed on the copy.

Follow the procedures of the court or U.S. Attorney involved, if their methods differ from the above.

When an inspection is made pursuant to a warrant, a Return showing the inspection was completed must be made to the Judge (or U.S. Commissioner or Magistrate) who issued the warrant. The Return, executed on the original warrant, should be made promptly and usually no later than 10 days following its execution.

 5.2.7 - DISCUSSIONS WITH MANAGEMENT

After completion of the inspection, meet with the highest ranking management official possible to discuss your findings and observations. The FDA 483 is not a substitute for such discussion since there may be additional questionable practices or areas not appropriate for listing on this form.

During the discussion be frank, courteous and responsive with management. Point out the observations listed on the FDA 483, are your observations of objectionable conditions found during the inspection, and explain the significance of each. Try to relate each listed condition to the applicable sections of the laws and regulations administered by the FDA.

If significant deviations are observed during the inspection, youHighlighted to denote updated text should inform management during the closeout discussion, the conditions observed may, after further review by the Agency, be considered to be violations of the Food, Drug and Cosmetic Act or other statutes. Legal sanctions available to FDA may include seizure, injunction, civil money penalties and prosecution .

Do not be overbearing or arbitrary in your attitude or actions. Do not argue if management voices a different view of the FDA 483 observations, or of your opinions. Explain, in your judgment the conditions you observed MAY be determined by the FDA, after review of all the facts, to be violations. Make clear the prime purpose of the discussion is to call attention to objectionable practices or conditions, which should be corrected.

Obtain management's intentions regarding correcting objectionable conditions. They may propose corrections or procedural changes and ask you if this is satisfactory. If this involves areas where your knowledge, skill, and experience are such that you know it will be satisfactory, you can so advise management. Do not assume the role of an authoritative consultant. In areas where there is any doubt, you must explain to management you cannot endorse the proposed corrections. Advise the individuals their firm's response may impact FDA's determination of the need for follow-up action, if FDA receives an adequate response to the FDA 483 within 15 business days of the end date of the inspection.  A record of the firm's response should be entered into FACTS 483 Firm Response screen.  See update to Field Alert #29. FDA will supply comments (see RPM 4-1-3 #4) if the establishment will submit its request and its proposed corrections or procedures in writing to the district office.

Concentrate on what needs to be done rather than how to do it. Do not recommend the product or services of a particular establishment. If asked to suggest a product or consulting laboratory, refer the inquirer to a classified directory or trade publications and or organizations.

Report in your EIR all significant conversations with management or management representatives. In most instances it is not necessary to quote management's response verbatim. Paraphrasing the replies is sufficient. However, if the situation is such that quoting the reply or replies is necessary, enclose them in quotation marks.

 5.2.7.1 - Protection of Privileged Information

You have certain responsibilities under the FD&C Act, Section 301(j); Sections 359(d) and 306(e) of the Public Health Service Act; and Section 1905 of the Federal Confidential Statute (18 U.S.C. 1905) regarding protection of confidential material obtained during your official duties. See IOM 1.4.

Do not volunteer information about other firms or their practices. Ignore casual exploratory questions or remarks from management about competitors or their processes. Your casual and seemingly innocuous remarks may reveal privileged information. Therefore, be alert and avoid voluntarily or unknowingly divulging information, which may be privileged or confidential and possibly compromise FDA's and your own integrity.

Management often request copies of any documents or records you obtain from their firm. There is no objection to your supplying these. When management requests copies of photos taken by you in a plant, follow IOM 5.3.4.5.

You may encounter situations when management invites outside individuals to observe the inspectional process (e.g., representatives from the press, trade associations, congressional staff, other company officials). As discussed in Section 5.1.4.3 of the IOM, the presence of representatives invited by the firm should not disrupt the inspectional process. You are to continue the inspection in a reasonable manner.

If the firm allows invited individuals to photograph, videotape, or prepare audio recordings during the inspection, you should make every effort to protect privileged information in your possession. However, it is the Agency's position that it is the firm's responsibility to protect confidential and/or proprietary information observed or recorded by those individuals invited by the firm. Where applicable, refer to IOM 5.3.5 for additional procedures on how to prepare your own recording in parallel with the firm's recording.

 5.2.7.2 - Refusals of Requested Information

Should management refuse to provide any reasonable request for information, which is not specifically required by the law, determine the reasons for the denial and report the details in the EIR. Types of refusals of interest to FDA and refusal codes to be entered in FACTS are listed in the FDA Data Codes Manual. Refusal codes' data are used when reporting to Congress. See IOM 5.2.5.4 for instructions in dealing with hostile and/or uncooperative interviewees.

 5.2.8 - CONSUMER COMPLAINTS

Prior to conducting any inspection, you should review the FACTS system and the factory jacket becoming familiar with all FDA Complaint/Injury forms. Be especially alert for ones marked "Follow-Up Next Inspection" and make sure you investigate these during your inspection.

During the inspection, discuss these complaints with management without revealing the complainant's name(s). Determine if the firm has had similar complaints on the same product. Determine what action the firm has taken to identify the root cause of the problem and to prevent a recurrence in the future. See IOM 5.10.4.3.11 for reporting instructions.

 5.2.9 - INTERVIEWING CONFIDENTIAL INFORMANTS

When you are faced with a situation involving sources of information who want to remain anonymous, please contact your supervisor and follow the procedures here. In addition, refer to IOM 5.2.1.2 regarding your personal safety. If your management concurs with the decision to utilize a confidential source, it is particularly important you take the necessary steps to keep the identity of the source, and any information which could lead to the identity, confidential. For purposes of this subchapter, a confidential source is a person who provides information that may be of assistance to FDA without necessarily becoming a party to the actual FDA investigation. If you believe the information provided by the source could lead to a criminal investigation, please contact the Office of Criminal Investigations (OCI).

 5.2.9.1 - How to handle the first contact

When you interview a person who may become a confidential source use the following procedures:

  1. Type of meeting. Try to schedule a personal interview with the person rather than a telephone interview. At a face-to-face interview you can assess the person's demeanor, body language, overall presentation, and truthfulness.
  2. Meeting location. The place and time of the interview should be the choice of the person, unless there is a concern with personal safety. If the person's suggested location is unsuitable, the investigator should suggest the location. When you conduct the interview off FDA premises, notify your supervisor of your destination, purpose, and estimated time of return. When an off-site interview has been completed, check-in with your supervisor.

 5.2.9.1.1 - INTERVIEWING METHODS/TECHNIQUES

It is strongly recommended you have two investigators conduct interviews of a confidential source. The lead investigator conducts the interview, while the second investigator takes notes and acts as a witness to the interview. You should:

  1. Prepare carefully for the interview. The investigators should develop the questions they intend to ask the person during the interview, e.g., "establish motivation," and record and number the questions to be asked in their diaries prior to the interview. This preparation assists in documenting the interview process and reduces the amount of note taking needed during the interview. The investigators also should discuss their interviewing strategy, and determine the method by which they will consult with each other during the interview and (during extensive interviews) share the interviewing and note-taking responsibilities;
  2. Have the person tell the story chronologically, placing complex situations into logical order; and
  3. If the person makes allegations, ask him or her how he or she knows the allegations are true.
    1. How were they in a position to know?
    2. Did they personally see, hear, or write about the information/incident?
    3. Can they provide proof of the allegations?

 5.2.9.1.2 - ESTABLISH MOTIVATION

At the end of the interview ask the person why he or she is divulging this information. This may reveal their motive(s):

  1. Is the person a disgruntled current or former employee who harbors a grudge?
  2. Is the person looking for some type of whistle-blower reward or notoriety?
  3. Does the person just want to do the right thing?
  4. Is the person involved in actual or prospective litigation about or related to the information?

 5.2.9.1.3 - ANONYMITY

If the person is requesting anonymity, inform him or her FDA:

  1. Will not divulge his or her identity, the occurrence of the interview, or the sensitive information provided to FDA if the information could lead to the identity of the person, unless FDA is required to disclose the information by law, e.g., the investigation leads to a hearing or trial and he or she is required to testify, and
  2. Will try to corroborate all information provided by the person, minimizing the chances he or she must later testify. However, testifying remains a possibility.

Ask the person for names of other persons who might be willing to speak with you about the allegations and corroborate their story.

 5.2.9.2 - Protect the Identity of the Source

Collection of information. Obtain sufficient personal information necessary to enable you to contact the person for follow up if needed. However, to maintain the confidential-ity of the person, do not include the person's identifier information such as gender, name, address, and phone number in the memorandum of interview. You should assign the confidential source a code name or number and use the identifier in memoranda and other communications relating to the confidential source (see IOM 5.2.9.2.2 item 2).

 5.2.9.2.1 - ACCESS

Know who is authorized by District procedure to access the information, and restrict access by others accordingly. Share the minimum amount of information necessary to meet the purpose of the disclosure.

 5.2.9.2.2 - STORAGE REQUIREMENTS

Each district should establish procedures, in addition to those listed below, to properly store confidential information. The following list contains information related to storage procedures.

  1. Use security measures necessary to protect the confidentiality of personal information, whether it is in hard copy or electronic form, on FDA premises, in an FDA home-based computer, or in any other form. Use whatever means necessary and appropriate to physically safeguard the information, such as storing in a safe, or locked file cabinets, or password-coded computers, etc.
  2. When referring to the source in any manner (orally, in writing, electronically, etc.), consider using code to identify the source. For example, use a number rather than the individual's name, to identify the source. Personal privacy information should be safeguarded. Use discreet subject headers in the file labels as appropriate.
  3. Remove personal information from a file only after you have noted in the file your name, date, etc. Promptly return that information to the file.

 5.2.9.2.3 - DISCLOSURE

Do not disclose information from or about the source, unless the disclosure complies with the law and FDA's procedures. Do not share non-public information outside of the Freedom of Information (FOI) process, unless the sharing is done according to our regulations and procedures. Refer FOI requests to your FOI officer (see item 3 below). See also IOM Subchapter 1.4. The following information relates to disclosures of information from or about a confidential source.

  1. Make duplicates of the personal information only to the extent necessary for authorized disclosure (inside or outside of FDA). Do not leave the copy machine unattended.
  2. Make only authorized disclosures of the information, regardless of the manner of disclosing (oral, written, etc.). Do not use mobile telephones or leave voice mails with the information. Avoid transmitting the non-public information by facsimile or e-mail.
  3. If you receive a FOI request for information from or about a source consult with your supervisor immediately Disclosure to a non-FDA government official of information from or about a source may be disclosed only if permitted by law and FDA procedures, and after consulting your supervisor and, if needed, OCI.
  4. Immediately retrieve information from or about a source is inadvertently disclosed.

 5.2.9.2.4 - DESTRUCTION

Destroy personal information by shredding or similar means which physically destroys the record and/or, if the information is in electronic form, makes it unreadable.

After a matter has been referred to the Office of Chief Counsel (OCC) for litigation or enforcement action, consult with OCC if you are interested in contacting the source.

 5.2.10 - ROUTINE BIOSECURITY PROCEDURES FOR VISITS TO FACILITIES HOUSING OR TRANSPORTING DOMESTIC OR WILD ANIMALS

This section is FDA's guidance when you visit any type of facility where any domestic or wild animals are housed or transported. If a firm has more restrictive controls, follow those in addition to the controls cited below as long as they do not interfere with your assignment needs. The controls and procedures are intended to prevent you from becoming a vector or carrier of animal diseases, to prevent the spread of animal disease, and to set a good example for stockmen, growers and industry servicemen. A number of chronic diseases, such as Johne's Disease, bovine virus diarrhea (BVD) and others exist in domestic animals which you can unknowingly spread. Any inspectional contact with herds of livestock (including poultry) or non-domesticated animals exposes you to potential claims of introducing or spreading disease. This could occur between sections of a single site, such as poultry houses, or between different sites or farms. The potential also exists for the introduction of disease from an animal processing plant, such as a slaughterhouse or renderer to a live animal facility. You can prevent this by following appropriate cleaning and disinfection steps between facilities. Generally, a break of 5 days or more between sites is sufficient to eliminate concern about transmission of infectious agents.

These precautions, biosecurity measures, are necessary in two types of situations. The first is when there is no known disease present and your actions are precautionary. This section primarily addresses those kinds of activities. The other situation involves known or suspected disease outbreaks or more notorious disease conditions such as salmonella in eggs, infectious Laryngotracheitis, foot and mouth disease, vesicular stomatitis, and blackhead which can be highly contagious and spread from one group of animals to another by movement of people and objects between infected and non-infected groups. In these cases, special precautions must be taken to make sure you are not an unknowing vector for the spread of disease. See IOM 5.2.10.3.

If you will only be inspecting an office or house away from areas where animals are housed or kept, clean and suitable street attire may be sufficient. Be aware if you visit any area of a facility where animals have been, you should always sanitize, clean or change footwear and it may be necessary to change outerwear before visiting another animal site to prevent any possibility of transmission of disease.

Your vehicle may also transport infection if you drive through contaminated areas and may require frequent cleaning between sites.

 5.2.10.1 - Pre-Inspection Activities

When you know you are going to visit or inspect any animal production or holding facility, consider contacting the State Veterinarian and/or the Regional APHIS office to determine if there are any areas in the state under quarantine or special measures to control animal diseases. APHIS office locations can be found on their website. The State Veterinarian will be listed under Government Listings in your phone book and is listed at this website disclaimer icon . Regional Milk Specialists frequently working with State counterparts in the Interstate Milk Shippers program should contact these sources at least quarterly for updates. Ask for any special controls or procedures they recommend. Follow any guidance they offer in addition to the precautions in this section. You should also consider pre-notification of the facility following guidance in IOM 5.2.1.1, Pre-Announcement, unless your assignment does not allow pre-notification. If you elect to pre-announce the inspection, in addition to the normal contact, ask to speak with the person at the facility responsible for their biosecurity measures and find out what they require of employees and visitors. If their requests do not interfere with your ability to do your job, follow their requests as we do when inspecting sterile manufacturing facilities.

Make sure your vehicle is clean and has been recently washed. Commercial car washes are adequate as long as you check to make sure any dirt, manure or other debris, which may be present from a previous site, has been removed. Some facilities may require additional disinfection of tires upon entry to the premises. Ensure tires and floor mats are clean. Consider designating places in your vehicle for storage of clean, unused supplies and dirty or used supplies.

In addition to your normal inspectional tools, obtain the following equipment and supplies from your district:

  1. Laundered or disposable coveralls or smocks (coveralls are suggested because they give better coverage). If you are going to visit multiple facilities in one day or trip, obtain sufficient quantities so you can change into clean or unused clothing between each site.
  2. Disposable plastic gloves, rubber boots, which can be sanitized, and disposable shoe/boot covers. Rubber boots over which you place disposable shoe/boot covers are preferred.
  3. Reusable cloth or plastic laundry bag(s) for clothing to be laundered. (Disposable bags can be used.)
  4. Soap, water and disposable or freshly laundered individual hand (or paper) towels.
  5. Sanitizing solution(s) and equipment (brushes, bucket, tray, measuring devices, etc.) to permit you to properly sanitizing hands, boots, equipment and your vehicle. Most disinfectants will require removing organic matter before use and good brushes are essential to remove dirt from boots and other objects.

Make sure any equipment you take with you has been thoroughly cleaned and sanitized as necessary. Clip boards, briefcases, flashlights, inspectional sampling tools, coolers, brushes, buckets and other objects should be cleaned between uses as necessary and between visits to any suspected infected facilities. Disposable equipment should be used to the fullest extent possible.

Maintain copies of any applicable Material Safety Data Sheets (MSDS) for disinfectants with you in your vehicle. If the firm's management requests information on the disinfectants you are using, they may read or copy these MSDS. Be familiar with the instructions and precautions concerning use of disinfectants. Any disinfectant should be effective against known or suspected microbiological agents.

In the event of a foreign animal disease, contact the USDA, APHIS Veterinary Services area Veterinarian in Charge for additional precautions and procedures to follow. (See 5.2.10.3)

 5.2.10.2 - General Inspection Procedures

Always begin each day with a clean vehicle free from any visible dirt or debris. During the day, take precautions to minimize contamination of your vehicle. If your vehicle becomes obviously dirty with adhering mud or manure, clean it before visiting another animal facility. When you arrive at a facility where animals are located, check to see if there are designated parking spots or pads for visitors. If so, park your vehicle there unless directed otherwise by the firm. If there is no guidance, park well away from all areas housing animals. When you arrive, inquire about or reconfirm any biosecurity measures the firm employs. Confirm your actions are suitable and follow expectations of the facility when this does not interfere with your inspection ability. Follow steps requested by the firm to remove contamination from vehicles, which may include troughs or pools of disinfectants for tires or other control measures. Avoid driving through manure, mud or wastewater at these sites.

In general, entry to animal housing or feeding areas, corrals, calf pens, hospital pens or special treatment facilities should be avoided unless the assignment requires their inspection or there are specific reasons requiring entry. If you must visit the feeding area occupied by livestock or birds, first determine if any groups are infected with disease. Arrange to visit the known non-disease areas first. Do not handle any animals unless official duty requires such contact. Before leaving the area where you parked your car, put on protective clothing as described and proceed with the purpose of your visit; sanitizing hands (and gloves if worn) and boots as necessary during the visit or inspection.

General procedures:

  1. Wear rubber boots or other suitable footwear, which you disinfect upon arriving at the site and prior to departure. It is preferable to also place disposable foot coverings over your footwear, regardless of the type, after you have disinfected them. If the firm has footbaths, use them. Boots and footwear should be disinfected with any of the agents identified at the end of this subsection using a good brush. Clean and disinfect the brush(es) and bucket you use for these activities.
  2. Wash your hands with soap and water. If you are visiting a facility where a known animal disease is present or the firm's biosecurity protocol requires, wear disposable gloves.
  3. Wear disposable or freshly laundered coveralls, when appropriate. Some facilities may provide disposable coveralls and require visitors to shower in and shower out at their facilities. If requested by the firm and facilities are provided, you should follow those requests.
  4. Wear appropriate head coverings, as necessary. If you wear a head covering, clean and disinfect between facilities or use disposable head coverings.
  5. Minimize any materials you carry with you such as notebooks, flashlights, etc. to what is required. Consider keeping these things in clean plastic bags or containers between uses. Disinfect any of these types of items as best you can between visits to facilities or between different animal-housing areas.
  6. If you are visiting production units with animals of multiple ages, always try to work from the youngest to the oldest.
  7. Avoid direct contact with livestock or wild animals, bodily fluids or animal byproducts when visiting facilities.
  8. Regional Milk Specialists, Milk Safety Branch and State Training Team staff frequently working with State counterparts in the Interstate Milk Shippers program shall follow any biosecurity measures the firm employs, any biosecurity measures the State employs, and as a minimum shall follow the coded memoranda issued by CFSAN Milk Safety Branch on this subject.

Upon completing your assignment in a given animal area, return to the same area where you donned protective clothing. Remove disposable shoe/boot covers and gloves, if applicable, and place them in a disposable paper or plastic bag. Clean and sanitize boots/footwear. Remove the protective clothing, if applicable, by peeling it off inside out. (This keeps the surfaces exposed to contamination on the inside.) Unless the firm’s biosecurity plan prohibits removal of waste from their premises, all waste should be disposed of by the investigator as follows: Place all disposable items in a disposable, nonporous bag for appropriate disposal according to State and/or local regulations. Place reusable coveralls or other reusable protective clothing in a separate bag for disposition at the office.

Follow guidance on biosecurity provided in the applicable Compliance Program or "Guide to the Inspection of "***" in addition to precautions in this Section.

Repeat these procedures for each separate location visited or inspected.

Purchase commercially available solutions for disinfecting objects or consult with your servicing laboratory. Commercial products such as Nolvosan, Efersan, One Stroke Environ or Virkon-S may be used as long as they are registered by EPA for the intended purpose. Lye or chlorine based cleaners and disinfectants may also be used.

The following formula for household bleach may be used. Mix 3/4 cup (6 oz) of liquid bleach (5.25%) in one gallon of water (128 oz). This solution will be approximately 1:20 dilution. Formulations of household bleach, which are more concentrated than 5.25% are commercially available. Dilute accordingly to these directions. A more concentrated 1:10 solution (1-oz bleach to 9-oz water) may be used with decreased contact time required. Dilutions should be prepared fresh daily and protected from light.

You should read the label and be familiar with directions and precautions, such as removing any organic matter from objects to be disinfected, for any disinfectant you use. In the absence of directions or for chlorine solutions you prepare: 1. Remove visible dirt from the object (boots, tools, tires, etc.). 2. Wipe, brush or scrub surfaces with the solution and keep wet for 2 minutes. 3. Allow to air dry or dry with previously sterilized toweling.

 5.2.10.3 - Special Situation Precautions

If you are required to inspect or visit a facility known or suspected to be involved in a contagious animal disease an outbreak or otherwise identified as having diseased animals, contact the Center for Veterinary Medicine and/or Center for Food Safety and Applied Nutrition for additional precautions which may be necessary before you visits these sites. Your activities may be limited to visiting a single site in a day, taking extra-ordinary decontamination steps, ensuring you do not visit or inspect another facility for 5 or more days following the visit to the contaminated site or other steps. APHIS may have special restrictions or precautions for you to follow. The State Veterinarian may also request you follow additional requirements. During inspections of poultry operations where salmonella contamination is known or suspected, you should make sure you contact CFSAN directly for specific procedures to follow. Additional decontamination steps will be required.