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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 5.10 - REPORTING

SUBCHAPTER 5.10 - REPORTINGHighlighted to denote updated text
5.10.1 - ESTABLISHMENT INSPECTION REPORT (EIR)
5.10.2 - ENDORSEMENT
5.10.2.1 - Compliance Achievement Reporting System (CARS)
5.10.2.1.1 - REPORTING CRITERIA
5.10.2.1.2 - DATA ELEMENTS
5.10.3 - FACTS ESTABLISHMENT INSPECTION RECORD (EI RECORD)
5.10.4 - NARRATIVE REPORT
5.10.4.1 - Non-Violative Establishments
5.10.4.2 - Violative Establishments
5.10.4.3 - Individual Narrative Headings
5.10.4.3.1 - STANDARD NARRATIVE REPORTHighlighted to denote updated text
5.10.4.3.2 - SUMMARY
5.10.4.3.3 - ADMINISTRATIVE DATAHighlighted to denote updated text
5.10.4.3.4 - HISTORY
5.10.4.3.5 - INTERSTATE (I.S.) COMMERCE
5.10.4.3.6 - JURISDICTION (PRODUCTS MANUFACTURED AND/OR DISTRIBUTED)
5.10.4.3.7 - INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVIEWED
5.10.4.3.8 - FIRM'S TRAINING PROGRAM
5.10.4.3.9 - MANUFACTURING/DESIGN OPERATIONS
5.10.4.3.10 - MANUFACTURING CODES
5.10.4.3.11 - COMPLAINTS
5.10.4.3.12 - RECALL PROCEDURES
5.10.4.3.13 - OBJECTIONABLE CONDITIONS AND MANAGEMENT'S RESPONSE
5.10.4.3.13.1 - Supporting Evidence and Relevance
5.10.4.3.13.2 - Discussion with management
5.10.4.3.14 - REFUSALS
5.10.4.3.15 - GENERAL DISCUSSION WITH MANAGEMENT
5.10.4.3.16 - ADDITIONAL INFORMATION
5.10.4.3.17 - SAMPLES COLLECTED
5.10.4.3.18 - VOLUNTARY CORRECTIONS
5.10.4.3.19 - EXHIBITS COLLECTED
5.10.4.3.20 - ATTACHMENTSHighlighted to denote updated text
5.10.4.3.21 - SIGNATURE
5.10.5 - EXHIBITSHighlighted to denote updated text
5.10.5.1 - Electronic Information
Highlighted to denote updated text
5.10.6 - ADDENDUM TO EIR 

SUBCHAPTER 5.10 - REPORTING

Following an inspection, you are required to prepare a report of your findings. Reporting includes the data and summary entered using FACTS, exhibits and attachments collected as evidence or for informational purposes and a narrative report. Your narrative report should be prepared to accurately and concisely communicate the findings of your inspection and be adequate for its intended use. For example, an inspection of a new firm, one that FDA has not inspected previously, should be a comprehensive inspection focused on assessing the firm’s compliance with applicable regulations. The resulting report would detail the products manufactured, the processes used to manufacture those products, the conditions of the environment in which products are manufactured or stored, any violations observed, persons responsible for the firm’s operations, their actual duties and their responsibility for observed violations, distribution practices, and so on, providing information responsive to each of the required elements.

For establishments that have been previously inspected, you should determine what changes in operations and responsible individuals have occurred since the previous inspection, detail those changes in the narrative report and report on the areas of concern for the current inspectional outcome. For example, a non-violative inspection may only require a Summary of Findings report with the information required in the Summary, Administrative Data, General Discussion with Management, Voluntary Corrections, Refusals, Samples Collected, Exhibits Collected and Attachments (see IOM 5.10.4.1).

An OAI follow-up inspection that reveals continuing violations supporting a regulatory action would require the Summary, Administrative Data, Individual Responsibility and Persons Interviewed, Objectionable Conditions and Management’s Response, Supporting Evidence and Relevance, Discussion with Management, Exhibits Collected, Attachments, and if appropriate, Refusals, Samples Collected, and Voluntary Corrections. Additionally, any information related to changes in previous operations would also need to be included in this type of report.

The key for you to remember in writing your narrative report is to communicate the findings of your inspection so that others may take the appropriate action. Notice that the required elements always include the product, interstate commerce, the violations observed and responsibility of firm officials. This is to document the elements of proof – Jurisdiction, Interstate Commerce, Violation and Responsibility (JIVR). Write your EIR with the intended use in mind. Your report may be a brief summary of an inspection of a firm in a state of compliance with applicable regulations all the way to a firm where the agency must take regulatory action to correct deficiencies.

 5.10.1 - ESTABLISHMENT INSPECTION REPORT (EIR)

See IOM 1.1 English language requirement. The EIR consists of the following in this order: a printed copy of the FACTS Establishment Inspection Record (EI Record) including, at least, the endorsement with the EIR distribution printed at the bottom of the "endorsement" section of the EI Record; carbon or other copies of FDA forms issued during the inspection such as the FDA 482FDA 483, and FDA 484; investigator's narrative report; copy of assignment if available; exhibits; and/or any additional material attached and referred to in the narrative report. Regarding the use of checklists that are completed during the inspection (such as the BSE Checklist), the original checklist should be submitted with the EIR. If you maintain the data in your regulatory notes, instead of entering the data directly on the checklist during the inspection, then a copy of the checklist that was completed using the data from your regulatory notes should be printed from FACTS and included with the EIR.

No copies of inspection reports will be maintained other than in headquarters, district, and resident post files. The signed original report is maintained in the district office or in the case of foreign inspections in the appropriate Center HQ office.

 5.10.2 - ENDORSEMENT

The endorsement of the establishment inspection is prepared by the supervisor. Some supervisors may have the investigator prepare proposed endorsements. Endorsements should fit in the available space provided in FACTS. If the endorsement exceeds the 2000 character space provided in FACTS, a separate endorsement should be prepared, fully identifying the firm with a Summary of the Endorsement included in FACTS. The FACTS EI Record will be printed and used as the endorsement and routing document to accompany the EIR. See also IOM 5.10.4.1.

Normally the endorsement consists of:

  1. The reason for the EI, i.e., workplan, or assignments from headquarters. State the subject of the assignment and reference. If the assignment was issued hard copy (i.e. not through FACTS), it should be attached to the EIR following the narrative.
  2. A brief history of previous findings including classification of previous EI, any action taken by the district and/or corrective action taken by the firm in response to inspectional observations from the previous inspection.
  3. A concise summary and evaluation of current findings and samples collected.
  4. Refusals, voluntary corrections or promises made by the firm's management.
  5. Classification and follow-up consistent with inspectional findings and Agency policy including notification of other districts and headquarters as warranted.
  6. Distribution consistent with District policy and the requirements of the specific Compliance Program and requirements as noted in IOM 1.7.3.

Note: Route a copy of the FACTS Establishment Inspection Record and the EIR to Division of Import Operations (DIO) when any violative, imported products are identified. Per CPG 110.300, do not report the FURLS Registration number.

The existence of Personal Safety Alerts (IOM 5.2.1.3) or Personal SafetyHighlighted to denote updated text Plans (IOM 5.2.1.4) pertaining to the firm should be included in the endorsement section only and not in the EIR.

The signed endorsement should be updated to indicate if an addendum to the EIR (IOM 5.10.6) or an amended FDA 483 (IOM 5.2.3.1.6.1 and 5.2.3.1.6.2 Highlighted to denote updated text) has occurred.

PROFILES: Updating the Field Accomplishments and Compliance Tracking System (FACTS) database with a Compliance Status for each profile class code associated with the firm's operations and/or products, is the responsibility of Field and Center Investigators, Supervisors and Compliance Officers. 

For Domestic inspections, hardcopy or e-mail notification of Potential OAIs are not necessary.  FACTS automatically sends OAI Notifications to OEIO/DCSelectronically. 

For foreign inspections, when a potential OAI Notification cannot immediately be entered in the FACTS firm profile record, the investigator should notify the Division of Food and Feed ProgramHighlighted to denote updated text Operations and Inspections (CFSAN or CVM products) or the Division of Medical Products and Tobacco Inspections (CDER, CBER, CDRH, or CTP products) of the potential OAI situation via FAX (301 -827-9791)Highlighted to denote updated text as soon as the potential OAI situation is known and during the investigation.  DFFPHighlighted to denote updated textOI or DMPTI will then notify the appropriate Center.

See Exhibit 5-14 for more information on profiling CGMP/QS Compliance Status.

 5.10.2.1 - Compliance Achievement Reporting System (CARS)

FACTS is used to report achieved and verified compliance actions, which are not the result of a legal action. A compliance achievement is the observed repair, modification, or adjustment of a violative condition, or the repair, modification, adjustment, relabeling, or destruction of a violative product when either the product or condition does not comply with the Acts enforced by the FDA.

 5.10.2.1.1 - REPORTING CRITERIA

There are three criteria for reporting into the CARS system:

  1. The detection or identification of the problem. A problem may be observed by FDA, other federal officials, or by state or local authorities and referred to FDA; and as a result of an inspection, investigation, sample analysis, or detention accomplished by ORA or states under contract to ORA.
  2. The correction of the problem. The correction is directly attributable to the efforts of ORA or state officials under contract to ORA (involving contract products only); and is unrelated to the filing of a legal action, i.e., seizure, prosecution, injunction.
  3. The verification of the correction of the problem. The correction is verified by the FDA, other federal officials or state or local authorities and reported in writing to the FDA; and is based on an inspection, investigation, sample analysis, or letter from a firm to FDA certifying the problem has been corrected.

 5.10.2.1.2 - DATA ELEMENTS

Only when the corrective action(s) has been verified should a CARS be reported. The data elements are those entered/coded in FACTS (See IOM Exhibit 5-15):

  1. PAC. See the Data Codes Manual. Should there be insufficient space to code all corrections verified on an occasion, record the most significant corrections.
  2. PROBLEM TYPE. The problem type is the problem(s) identified during the operation(s). Use the List of Values (LOV) found in this field on the Compliance Achievement Reporting Screen. If “Other” is chosen, you should include an explanation in the "Remarks" field.
  3. CORRECTIVE ACTION. The action the establishment took to correct the identified problem. Use the LOVs found in this field on the CARS screen. If "Other" is selected, you should include an explanation in the "Remarks" field.
  4. VERIFICATION DATE. Use the date the corrective action(s) is verified, either through an establishment inspection, an investigation, or a letter from the establishment certifying the corrections have been made. Include documentation to verify the action such as repair receipts/plans.
  5. CORRECTING ORGANIZATION. The FDA, other federal agency, or state or local authority, which observed the verified correction. Use the LOVs found in this field on the CARS screen.
  6. REPORTING ORGANIZATIONHighlighted to denote updated text. The FDA, other federal agency, or state or local authority, which is actually inputting the verified correction. Use the LOVs found in this field on the CARS screen.
  7. REASON FOR CORRECTION. The action the FDA took to make the correction happen. Use the LOVs found in this field on the CARS screen. If “Other” is chosen, you should include an explanation in the “Remarks” field.

 5.10.3 - FACTS ESTABLISHMENT INSPECTION RECORD (EI RECORD)

Per FMD-130, each ORA District is responsible to ensure all investigators verify, correct, and enter changes to the OEI (including Profile data for profilable firms) on the firm’s maintenance screens in FACTS during each inspection, investigation and during any OEI update. Consult with your supervisor and District OEI Coordinator to assure data is accurately updated. See IOM Exhibit 5-16 and 5-16. The FACTS generated assignment and FACTS Profile Data instructions are attached as IOM Exhibits 5-9 and 5-14.

Inspectional accountable time in FACTS consists of the hours devoted to file reviews (operational preparation), actual inspectional, investigational, time (onsite), document preparation exhibit and EIR (report) write-up. Accountable time does not include travel time. One occasional exception could be when more than one participant in an inspection/investigation travel together and discuss/prepare while in route.

 5.10.4 - NARRATIVE REPORT

See IOM 1.1 English language requirement. You should use Turbo EIR for all EIRs The narrative report is the written portion of the EIR, which accurately describes the investigator's inspectional findings. The narrative report may be prepared in two formats depending on the type of inspection and inspection classification. A Summary of Findings narrative report may be used for non-violative, non-initial inspections - see IOM 5.10.4.1. The full Standard narrative report is used for initial and potential Official Action Indicated (OAI) classified inspections - see IOM 5.10.4.3. The "Summary of Findings" report format may be used for some Voluntary Action Indicated (VAI) classified inspections as directed by your supervisor. Additional requirements for human drug and medical device reports are described in IOM 5.5.8 and 5.6.9. For all reporting formats, include additional information as directed by your assignment, Compliance Program Guidance Manual, or your Supervisor.

All reports should be prepared as stand-alone documents outside of FACTS. Your Establishment Inspection Report (EIR) should:

  1. Be factual, objective, and free of unsupportable conclusions.
  2. Be concise and descriptive while covering the necessary aspects of the inspection.
  3. Not include opinions about administrative or regulatory follow-up.
  4. Generally, be written in the first person using the active voice.
  5. Be signed by all FDA and commissioned personnel participating in the inspection. See IOM section 5.1.2.5.1 when more than one FDA or commissioned person participated in the inspection.

Refer to IOM 5.10.6 for an Addendum to EIR.

 5.10.4.1 - Non-Violative Establishments

Investigators should use "Summary of Findings", stand-alone, narrative reports for non-violative domestic establishments, unless otherwise directed by your supervisor, the assignment or the Compliance Program Guidance Manual.

The Summary of Findings Report may not be written solely in the FACTS provided "Inspection Summary" heading. The Summary of Findings report should include:

  1. The reason for the inspection;
  2. The date, classification and findings of the previous inspection;
  3. The actual inclusive dates of the inspection (these may be included as part of a header or in the body of the EIR.)
  4. The name of the person to whom credentials were shown and the FDA 482, Notice of Inspection was issued and the person's authority to receive the FDA 482. Explain if you were unable to show credentials or issue forms to top management. Include the name of the person to whom FMD-145 correspondence should be directed;
  5. The scope of the inspection; i.e., comprehensive or directed; and a brief description of the products, processes or systems covered during the inspection; the manufacturing codes and if necessary their interpretation.
  6. Significant changes (e.g., personnel, facilities, products, processes) since the previous inspection
  7. The significant findings if any;
  8. Management's response or corrections;
  9. Warnings given to management; and
  10. The investigator's handwritten signature.

 5.10.4.2 - Violative Establishments

For domestic inspections where regulatory action is being recommended and when the district has final classification responsibility, the inspection report should normally be submitted within 10 days to the District or Center Compliance Branch as per established procedures. Please note, that depending on the type and severity of the regulatory action, it may be necessary to submit the EIR in less than 10 days. You should consult with your supervisory investigator in these instances. Refer to FMD-86 and the RPM regarding other timeframes associated with non-violative inspections.

All violative EIR's should in addition to the information required for non-violative reports contain the following:

  1. The objectionable conditions or practices described in sufficient detail so someone reading the report will clearly understand the observation(s) and significance.
  2. The objectionable conditions or practices cross-referenced to FDA 483 citations, samples collected, photographs, or other documentation including exhibits attached to the EIR.
  3. Information as to when the objectionable conditions or practices occurred, why they occurred, and who is or was responsible, developed to the highest level in the firm.

 5.10.4.3 - Individual Narrative Headings

There are many acceptable ways of organizing a narrative report. The key is to cover the required information in IOM 5.10.4 and 5.10.4.2, or as required by the assignment, Compliance Program Guidance Manual, or your supervisor. The appropriate use of headings should not result in repetition of the same information in different sections. You are encouraged to create headings as necessary to present the inspectional findings in the most concise manner. For non-violative, a single heading such as “Summary of Findings” is sufficient (for exceptions, see IOM 5.10.4.1).  Turbo EIR should be used to generate the FDA 483. In certain instances, if you experience computer problems, do not delay the issuance of the FDA 483.  See IOM 5.2.3. You should use Turbo EIR for all EIRs.

 5.10.4.3.1 - STANDARD NARRATIVE REPORT

This is intended to outline the minimal information needed to produce a narrative report that supports further agency regulatory action, as warranted.  Investigators are encouraged to add additional report headings as needed to communicate important information about the inspection, relevance of inspectional observations that may impact public health, and /or to address specific requests from directed assignments.Highlighted to denote updated text

Comprehensive Reports (Include all applicable sections)Highlighted to denote updated text

A comprehensive EIR should be prepared for initial inspections in all program areas.   It is essential to describe the products manufactured , the process the manufacturing and storage environment, distribution patterns/interstate commerce, individual responsibility of key employees, history of business, all objectionable conditions observed, etc.   All things pertinent to the operations and management of the establishment should be included in these reports.   The comprehensive report may also be used for other situations requiring full reporting such as Routine Surveillance - OAI.  An abbreviated inspection does not necessarily equate to an abbreviated report.Highlighted to denote updated text

Required elements Highlighted to denote updated text

  • 5.10.4.3.2 – SummaryHighlighted to denote updated text
  • 5.10.4.3.3 – Administrative dataHighlighted to denote updated text
  • 5.10.4.3.4 – HistoryHighlighted to denote updated text
  • 5.10.4.3.5 – Interstate (I.S.) CommerceHighlighted to denote updated text
  • 5.10.4.3.6 – Jurisdiction (Products Manufactured and/or Distributed)Highlighted to denote updated text
  • 5.10.4.3.8 – Firm’s Training Program Highlighted to denote updated text
  • 5.10.4.3.9 – Manufacturing/Design Operations Highlighted to denote updated text
  • 5.10.4.3.10 – Manufacturing Codes Highlighted to denote updated text
  • 5.10.4.3.11 – Complaints Highlighted to denote updated text
  • 5.10.4.3.12 – Recall Procedures Highlighted to denote updated text
  • 5.10.4.3.13 – Objectionable Conditions and Management’s Response Highlighted to denote updated text
  • 5.10.4.3.13.1 – Supporting Evidence and Relevance Highlighted to denote updated text
  • 5.10.4.3.13.2 - Discussion with ManagementHighlighted to denote updated text
  • 5.10.4.3.14 – Refusals Highlighted to denote updated text
  • 5.10.4.3.15 – General Discussion with Management Highlighted to denote updated text
  • 5.10.4.3.16 – Additional Information
  • 5.10.4.3.17 – Samples Collected
  • 5.10.4.3.18 – Voluntary Corrections
  • 5.10.4.3.19 – Exhibits Collected Highlighted to denote updated text
  • 5.10.4.3.20 – Attachments Highlighted to denote updated text

Routine Surveillance – NAI ReportsHighlighted to denote updated text

When FDA has an inspectional history for the firm and no deficiencies were observed by the investigator, a brief report may be prepared.   The intent of this report is to include only the required information about the firm and what areas were covered during the inspection.   “Change reporting” means information that differs from the previous inspection report such as changes in management, products produced, manufacturing processes, etc.   Where these changes have occurred, the applicable section heading in the EIR should be included. The elements may also be captured in a “Summary of Findings Only” report without header information See IOM 5.10.4.1.Highlighted to denote updated text

Required elementsHighlighted to denote updated text

  • 5.10.4.3.2 – Summary Highlighted to denote updated text
  • 5.10.4.3.3 – Administrative data Highlighted to denote updated text
  • 5.10.4.3. 14 – Refusals Highlighted to denote updated text
  • 5.10.4.3.15 – General Discussion with Management Highlighted to denote updated text
  • 5.10.4.3.17 – Samples Collected Highlighted to denote updated text
  • 5.10.4.3.18 – Voluntary Corrections Highlighted to denote updated text
  • 5.10.4.3.19 – Exhibits Collected Highlighted to denote updated text
  • 5.10.4.3.20 – Attachments Highlighted to denote updated text

Change reporting onlyHighlighted to denote updated text

  • 5.10.4.3.4 – History Highlighted to denote updated text
  • 5.10.4.3.6 – Jurisdiction (Products Manufactured and/or Distributed) Highlighted to denote updated text
  • 5.10.4.3.7 – Individual Responsibility and Persons Interviewed Highlighted to denote updated text
  • 5.10.4.3.8 – Firm’s Training Program Highlighted to denote updated text
  • 5.10.4.3.9 – Manufacturing/Design OperationsHighlighted to denote updated text
  • 5.10.4.3.10 – Manufacturing CodesHighlighted to denote updated text

Routine Surveillance – VAI ReportsHighlighted to denote updated text

For firms with an inspectional history and the outcome of the inspection is a VAI classification, the below elements would be required, plus change reporting. Note that the difference in the NAI versus the VAI report is the inclusion of narrative addressing objectionable conditions observed during the inspection. Each objectionable condition or practice must be documented in the EIR along with discussion of the evidence, relevance and discussion with management.Highlighted to denote updated text

Required elementsHighlighted to denote updated text

  • 5.10.4.3.2 – Summary Highlighted to denote updated text
  • 5.10.4.3.3 – Administrative data Highlighted to denote updated text
  • 5.10.4.3.13 – Objectionable Conditions and Management’s Response Highlighted to denote updated text
  • 5.10.4.3.13.1 – Supporting Evidence and Relevance Highlighted to denote updated text
  • 5.10.4.3.13.2 - Discussion with Management Highlighted to denote updated text
  • 5.10.4.3.14 – Refusals Highlighted to denote updated text
  • 5.10.4.3.17 – Samples Collected Highlighted to denote updated text
  • 5.10.4.3.18 – Voluntary Corrections Highlighted to denote updated text
  • 5.10.4.3.19 – Exhibits Collected Highlighted to denote updated text
  • 5.10.4.3.20 – Attachments Highlighted to denote updated text

Change reporting onlyHighlighted to denote updated text

  • 5.10.4.3.4 – History Highlighted to denote updated text
  • 5.10.4.3.7 – Individual Responsibility and Persons Interviewedighlighted to denote updated text
  • 5.10.4.3.8 – Firm’s Training ProgramHighlighted to denote updated text
  • 5.10.4.3.9 – Manufacturing/Design OperationsHighlighted to denote updated text
  • 5.10.4.3.10 – Manufacturing CodesHighlighted to denote updated text

Routine Surveillance – OAIHighlighted to denote updated text

For an OAI surveillance inspection, follow the guidance under Comprehensive Reports.Highlighted to denote updated text

OAI Follow-up Inspection ReportsHighlighted to denote updated text

OAI follow-up inspections are inspections conducted following an OAI classified inspection. Inspections of this nature are conducted to determine whether corrective actions have been implemented or significant violations continue.   The outcome of these inspections may range from NAI to OAI.   The intended use of the EIR should be the driving force of the content of these EIRs.   Typically, the follow-up should be done relatively soon after the previous inspection, so changes to products, process, personnel, etc. should be minimal.   The NAI and VAI reports should focus on corrective actions implemented by firm management to correct the violative conditions observed during the previous OAI inspection.   Those reports may be Summary of Findings only or may follow the other NAI and VAI report formats above.   An OAI follow-up inspection may lead to a regulatory action such as seizure, injunction and/or prosecution.   Those reports should focus on documenting the continuing violations, responsibility for those violations, any corrective actions implemented or inadequate corrective actions and defining the new scope of violations observed including the products affected.   Scope should include additional lots, products, timeframe and distribution.   These reports should document all elements of JIVR (Jurisdiction, Interstate Commerce, Violation and Responsibility).   This allows for the report to support whatever regulatory action is deemed necessary. Highlighted to denote updated text

Required elementsHighlighted to denote updated text

  • 5.10.4.3.2 – Summary Highlighted to denote updated text
  • 5.10.4.3.3 – Administrative data
  • 5.10.4.3.7 – Individual Responsibility and Persons Interviewed
  • 5.10.4.3.13 – Objectionable Conditions and Management’s Response Highlighted to denote updated text
  • 5.10.4.3.13.1 – Supporting Evidence and RelevanceHighlighted to denote updated text
  • 5.10.4.3.13.2 - Discussion with Management Highlighted to denote updated text
  • 5.10.4.3.14 – Refusals Highlighted to denote updated text
  • 5.10.4.3.17 – Samples Collected Highlighted to denote updated text
  • 5.10.4.3.18 – Voluntary CorrectionsHighlighted to denote updated text
  • 5.10.4.3.19 – Exhibits Collected Highlighted to denote updated text
  • 5.10.4.3.20 – Attachments Highlighted to denote updated text

Change Reporting Only:Highlighted to denote updated text

  • 5.10.4.3.5 – Interstate (I.S.) Commerce Highlighted to denote updated text
  • 5.10.4.3.6 – Jurisdiction (Products Manufactured and/or Distributed)Highlighted to denote updated text
  • 5.10.4.3.9 – Manufacturing/Design Operations Highlighted to denote updated text
  • 5.10.4.3.10 – Manufacturing Codes Highlighted to denote updated text
  • 5.10.4.3.11 – ComplaintsHighlighted to denote updated text

 5.10.4.3.2 - SUMMARY

  1. Provide the reason for the inspection (e.g., compliance program, by assignment, etc.);
  2. The scope of the inspection (comprehensive, directed, sample collection only, QSIT level, etc.).
  3. Provide a summary of the findings, date, and classification of the previous inspection and the firm’s response/corrective actions.
  4. List the products, systems and processes covered during the current inspection, and the types of records and documents reviewed. For human drug reports, list the systems not covered.
  5. Provide a summary of the current findings, refusals, samples collected, warnings given to management, and a summary of management's response or voluntary corrections.
  6. Per CPG 110.300, do not report the FURLS Registration number.

 5.10.4.3.3 - ADMINISTRATIVE DATA

Administrative Data:

  1. The firm name, address, phone, FAX and e-mail address.
  2. Report the names and titles of the Investigator(s), Analyst(s), non-FDA officials, etc.  Report the name of the firm’s responsible official who gave permission to non-FDA officials without inspection authority to accompany you during your inspection.  See IOM 5.1.1 and 5.2.2.
  3. The inclusive date(s) of the current inspection, i.e., list the actual dates in the plant.
  4. If a team inspection and some individuals were not present during the entire inspection, indicate dates in plant for each team member.
  5. For foreign inspections with Locally Engaged Staff (LES)/Foreign Service National (FSN) participation include this language:

    This inspection was supported by ____________________ (during the period of __________), who is a Locally Engaged Staff (LES) hired by the United States Embassy and assigned to FDA to work in support of FDA activities. All information, including documents collected during this inspection and any translation from local language to English by ______________(LES) that supports the Form FDA 483, Inspectional Observations (if Form FDA 483 was issued) and the Establishment Inspection Report (EIR) was collected in collaboration with the FDA investigator(s).

    Highlighted to denote updated text

Report Full Names and Titles of:

  1. To whom FDA Official Credentials were shown,
  2. To whom any FDA forms were issued to or signed by during the inspection (FDA 482483484463, etc.); where appropriate, explain the reason a form(s) was not issued to or signed by the most responsible individual (this may be reported in the Individual Responsibility and Persons Interviewed heading below),
  3. Who wrote which section of the EIR, if this was a team inspection report,
  4. In-plant inspectors or other government agencies (IOM 5.4.9).
  5. For domestic and foreign food facilities, document to whom the FSMA Fee Information Sheet was provided to. See Field Alert 34.

 5.10.4.3.4 - HISTORY

History:

  1. Report the legal status of the firm (corporation, partnership, limited liability company, etc.). If a corporation, list in which state and when the firm was incorporated.
  2. List the parent corporation, corporate address and any subsidiaries.
  3. Provide a summary of any regulatory actions and prior warnings (do not cite any action only recommended but not approved). You should also report any significant/relevant inspectional history pertinent to the current EI or recommendation.
  4. Include any relevant recalls, etc. since the last inspection.
  5. Report the hours of operation and any changes from past inspections (include seasonal variations).
  6. Report the current registration(s) status or any changes to registration status. Per CPG section 110.300, do not report the FURLS Registration number. 
  7. If directions to the firm would be helpful in future visits, include the information.
  8. Provide the names, titles and addresses of top management official(s) to whom correspondence should be addressed (FMD 145, W/L, etc.).
  9. For foreign inspections, list U.S. consignees to whom the firm’s products are shipped.
  10. For Human Drugs - domestic firms, identify the general types of customers and provide the names and addresses for several regular customers of a few of the firm’s products.

 5.10.4.3.5 - INTERSTATE (I.S.) COMMERCE

Interstate (I.S.) Commerce:

  1. Report changes in the previous estimate of the percentage of products shipped outside of the state (or exported to the U.S.) and the basis of the estimate.
  2. Report the firm's general promotion and distribution patterns.
  3. If there is an apparent violative product, provide examples of I.S. shipments of violative product(s); or
  4. If no such shipments, provide examples of I.S. shipments of major components of apparent violative products - with complete I.S. documentation in either case.

 5.10.4.3.6 - JURISDICTION (PRODUCTS MANUFACTURED AND/OR DISTRIBUTED)

Jurisdiction (Products Manufactured and/or Distributed):

  1. Include a list of a representative number of currently marketed products subject to FD&C Act or other statute enforced by FDA or counterpart state agency, including any believed violative.
  2. Collect appropriate labeling (product and case labels, inserts, brochures, manuals, promotional materials of any type) for those products believed violative or representing any significant new or unusual operation, industry or technology; or as directed by your supervisor.
  3. Document any applicable labeling agreements (and obtain a copy) and statutory guaranty given or received per Sections 301(h) and 303(c)(2) of the FD&C Act [21 U.S.C. 321 (h) and 333 (c)(2)] (IOM 5.3.7.2)

In addition, the label, labeling and promotional materials are a critical part of determining a product’s intended use.

  1. In instances where a regulatory action is being considered based on product labels, labeling, and/or other promotional materials, including any Internet websites, you should collect all available documentation. This includes all written, printed or graphic matter on the immediate container of an article or accompanying the article (the product’s label and labeling, see FD&C Act, 201(k) and (m) [21 U.S.C. 321(k) and (m)] and IOM 4.4.9.1). Accompanying labeling could include brochures, pamphlets, circulars, and flyers, as well as audio and video tapes.
  2. In cases where there may be a dispute about whether a product is a drug or a dietary supplement, you should collect all materials which claim a product can be used for the treatment of any disease.

 5.10.4.3.7 - INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVIEWED

Report with whom you dealt, and in what regard (both during and prior to the start of the inspection):

  1. Who provided relevant information,
  2. Who accompanied you during the inspection,
  3. Who refused access to required records or any other refusal of information (Note: a separate heading for Refusals may be needed if refusals are significant, extensive or an Inspection Warrant is anticipated),
  4. Who refused to permit inspection (IOM 5.2.5.1) and
  5. For Human Drug inspection reports, also include the name, title, physical mailing address, phone, and fax number and e-mail address for any U.S. Agent or broker who represents the company when dealing with the FDA.

Describe roles and authorities of responsible individuals, including the full names and titles of individuals providing you with information.

Describe roles, authorities and responsibilities of officials at headquarter or corporate organizations for this firm; including their names, titles and addresses.

Report changes to the following:

  1. Who is the most responsible individual at the inspected firm?  Who is the responsible head or designated correspondent?  Refer to IOM 5.3.65.3.6.1, and 5.3.6.2.
  2. Report full names and titles of owners, partners, and corporate officers. Who has the duty, power and responsibility, and authority to prevent, detect, and correct violation(s), and how is this demonstrated and/or documented? See IOM 5.3.6.2.
  3. Report the chain of command; include an organizational chart (create if necessary).
  4. Obtain a copy of public annual report, if any.
  5. List the names and titles of key operating personnel.

 5.10.4.3.8 - FIRM'S TRAINING PROGRAM

The firm's training programs are of particular significance where inspectional findings find people may not be adequately trained.

 5.10.4.3.9 - MANUFACTURING/DESIGN OPERATIONS

Manufacturing/Design Operations:

  1. Report only changes to the firm's general overall operations, including significant changes in equipment, processes, or products since the previous inspection. Include schematics, flow plans, photographs, formulations and diagrams, if useful.
  2. List names and sources of new or unusual components or raw materials.
  3. Report equipment considered new or unusual unless otherwise directed.
  4. Submit pertinent formulas (especially those being manufactured during your inspection) and processing instructions with labeling of suspect products.

For human drug inspection reports:

This section of the EIR should be organized by system covered during the EI as outlined in CP 7356.002. In each section, include a brief summary of what you reviewed in order to meet the key system element outlined in the CP. You should add more detail for the system elements found to be deficient, or the subject of a FDA 483 observation.

For medical device inspection reports:

  1. Describe manufacturing operations by sub system covered in your inspection (Management Controls, Design Controls, Production and Process Controls, Corrective and Preventive Action Controls, Material Controls, Facility and Equipment Controls, and Records/Documents/Change Controls). For ALL Level 2, 3, and "for cause" inspections: for production and process controls - indicate which production processes were covered/reviewed. If a subsystem was not specifically covered during your EI, you do not need to separately describe the general operations of that subsystem.
  2. For all inspections covering CAPA - indicate which data sources were available for review and which were actually reviewed; include a brief statement regarding coverage or non-coverage of applicable tracking requirements, MDRs, sterilization, and reports of corrections and removals.
  3. If the Design Control system was covered, indicate the design project(s) covered during the inspection. Where design activities occur at a location other than the manufacturing site, list the name, address of the design location and responsibilities of those performing the design activities.
  4. If applicable, identify the name and address of the specification developer if different from either the manufacturing site or where design activities occur.

 5.10.4.3.10 - MANUFACTURING CODES

Manufacturing Codes

  1. If the manufacturing codes are unchanged, include a statement in the EIR the system is the same as described in reports on file at the District. Indicate the date of the EIR in which the codes are fully explained.
  2. If the manufacturing codes have changed, describe the manufacturing coding system (lot, batch, product, etc.), and a key to interpretation of codes.
  3. For medical device inspections reports: where appropriate, include a description of the system used to identify and maintain control of components during the manufacturing process, as well as, the codes used for traceability (for applicable finished devices).

 5.10.4.3.11 - COMPLAINTS

Note: These complaints include those reported to the FDA by consumers, health care professionals, industry, etc.; and all complaints received by the firm.

  1. Report your review of the firm’s complaint file(s).
  2. In addition, if returned goods and/or documents for returned goods are examined, describe findings. If not examined, so indicate.
  3. Report your follow-up of consumer/trade complaints, Adverse Event Reports, MDR's, MedWatch reports or recalls identified in the district factory jacket for coverage. Correlate consumer/trade complaints, Adverse Event Reports, MDR's, MedWatch reports to specific objectionable conditions observed.

 5.10.4.3.12 - RECALL PROCEDURES

Describe plans and procedures for removing products from marketing channels if necessary. If these procedures are in written SOP-type format, you may reference any copies obtained to aid in your explanation.

 5.10.4.3.13 - OBJECTIONABLE CONDITIONS AND MANAGEMENT'S RESPONSE

If any observations were provided to management in writing (FDA 483) at the conclusion of the inspection list each observation and report each observation providing information organized under the two headings Supporting Evidence and Relevance, and Discussion with Management below.

NOTE: Observations of a verbal nature (i.e., Discussion Items) should be reported in sufficient detail under the General Discussion with Management (correlate any Exhibits, samples, etc. to any "verbal" observations).

 5.10.4.3.13.1 - Supporting Evidence and Relevance

Sufficiently describe the observation as necessary to relate the facts as you found them.

  1. Identify specific pages of exhibits and/or samples (e.g., procedure title, section, paragraph, sentence), labeling text, interstate shipping records which in your judgment document violations so supervisors, compliance officers, and other reviewers can readily evaluate your evidence.
  2. Describe verbal statements (verbatim if possible) by firm officials having knowledge, duty, power, and responsibility to detect, prevent, or correct the apparent violation. 
  3. Identify the responsible party for each apparent violation (i.e., if known.)
  4. Identify which team member (if applicable) was responsible for the observation.
  5. When appropriate explain how this observation relates to the overall situation; i.e., impact on the product, batches, or lots involved, and any relationship to other products, processes, or other FDA 483 observations.
  6. The duration of the problem.

 5.10.4.3.13.2 - Discussion with Management

Discussion with management:

  1. Report management's response to each specific observation, time frames given for corrections and/or corrective action. 
  2. Report any disagreements with or refusals to correct the observation.

For medical device inspection reports:

  1. For each observation based on sampling of records, indicate which Sample Table and level of confidence was used and the actual number of records sampled.
  2. If the number sampled is different than the actual number reviewed, so indicate.

 5.10.4.3.14 - REFUSALS

Provide full details of all refusals of/for requested information, statutory information, photography, entry, etc. received during the inspection, including who made the refusal and, if available, why the refusal was given.

 5.10.4.3.15 - GENERAL DISCUSSION WITH MANAGEMENT

General Discussion with Management:

  1. Report the names and titles of all present, including those present via electronic media (describe).
  2. Include the name and title to whom the FDA 483 was issued.
  3. Provide additional discussion items not provided in writing at the conclusion of the inspection, such as: questionable labels, labeling and/or labeling practices, commercialization of products covered by IDE or IND, fraudulent health claims, registration/listing deviations, lack of approved PMA, 510(k), NDA, ANDA, etc. These include all verbal observations deemed not to merit inclusion on the FDA 483 (IOM 5.2.3)
  4. A description of each warning, recommendation, or suggestion given to the firm, and to whom given.
  5. Management's general responses to the inspection and/or to groups of items listed on the report of observations or discussed at the conclusion of the inspection.

 5.10.4.3.16 - ADDITIONAL INFORMATION

Report changes as appropriate.

  1. Describe contractors used and for what purpose. For Medical Device inspection reports: also include names and addresses of all applicable third party installers or servicing organizations used by the manufacturer. Include their responsibilities.
  2. Describe suppliers (major raw material, active ingredient, etc.) used and for what.
  3. During inspections, when violative products imported into the U.S. or intended to be imported into the U.S., are encountered, document the product and foreign manufacturer in the EIR. Violative products could be rejected APIs due to non-conformance with the USP, foods without appropriate labeling, etc.  Send a copy of the EIR to OEIO/DIO. See IOM 5.2.1 and 5.10.2.
  4. For initial inspections, verify distribution patterns for the firm’s products, raw materials, and components to firms which warehouse or further process products which may be subject to FDA regulations. Districts should incorporate information obtained into their Official Establishment Inventory improvement activities and complete form FDA 457, Product/Establishment Surveillance Report as appropriate. See IOM 8.6.2.
  5. Report pertinent facts, which do not fit another section of the EIR. (For firms located in foreign countries, include information relative to lodging and travel; for domestic firms, include information relative to location of firm if difficult to find; etc.).

For human drug inspection reports - PDMA Coverage:

  1. Describe what sample loss, theft, or diversion reports were covered during the inspection.
  2. Describe the firm's sample audit and security systems, including a review of the firm's SOP's. Significant problems which may contribute to the firm's inability to adequately monitor sample distribution via sales representative, mail or common carrier should be addressed under objectionable conditions.

 5.10.4.3.17 - SAMPLES COLLECTED

List and describe samples collected during the inspection.

 5.10.4.3.18 - VOLUNTARY CORRECTIONS

Voluntary Corrections:

  1. Provide a brief description of improvements initiated by the firm in response to a previous inspection, report of observations and/or a warning letter.
  2. Report voluntary destructions, recalls, and similar actions since the prior inspection or during this inspection.
  3. Report any follow-up to recalls identified during the inspection (may be by referencing Attachment B recall report).
  4. Include recalls to specific objectionable conditions observed.
  5. Provide the identity of person(s) responsible for the corrections.
  6. Report any appropriate voluntary corrections in FACTS CARS

 5.10.4.3.19 - EXHIBITS COLLECTED

List all exhibits attached. See IOM 5.10.5, Exhibits.

Briefly, describe or title each exhibit attached. You should include in your description the number of pages for each Exhibit listing.

NOTE: For complex inspections a cross-reference from the FDA 483 and verbal observations to applicable exhibits and samples can be useful during further review.

 5.10.4.3.20 - ATTACHMENTS

Attachments as referred to here are any material not provided by the firm during the inspection and referred to in the EIR, which are not evidentiary in nature; such as assignments, Center provided protocols, website information printed during inspectional preparation, Highlighted to denote updated text etc. Non-evidentiary material attached to the narrative portion of the EIR should be identified as "Attachments" similar to IOM 5.3.8.2. Documents attached to the EIR may be referred to under the attachments heading, such as the FDA 482FDA 483, copy of the FDA 463a, etc. (in form number order); but such documents/forms may not be numbered, altered from their issued state, bear adhesive identification labels, etc. See the opening sentence of IOM 5.10.5. List and attach copies of associated reports (Recall Attachment B Report, etc.).

 5.10.4.3.21 - SIGNATURE

All participants will sign the final narrative portion of the EIR. The prescribed format is to type each persons name, title, and district (or other affiliation) below the signature. In some cases immediate signature by all participants is not possible. An example as to how this can be accomplished is to forward an electronic "draft" copy of the EIR for all to read and approve, then followed or accompanied by the original signature sheet. When signed, return to the lead investigator for proper filing and routing. When using this method, a photocopy of the original signature page is made with the lead investigator's signature and temporarily attached to the EIR.

 5.10.5 - EXHIBITS

Exhibits are materials collected from the firm during the inspectionHighlighted to denote updated text and do not include FDA forms, copies of assignments, or information obtained outside of the firm. For example, website downloads printed prior to the start of the inspection are not exhibits. Collect only records and documents which are pertinent to the inspectional findings or are required by assignment or Compliance Program. Highlighted to denote updated text Exhibits should contribute to the objective of the assignment and the clarity of the report. They may include flow-plans, schematics, layouts, etc.  Additional exhibit examples include copies of procedures or batch records that relate to and provide evidence of a violation.  The exhibits should be discussed and referenced in your narrative report and attached to the final Establishment Inspection Report. Highlighted to denote updated text If the materials collected from the firm are not needed as exhibits, they should be destroyed in accordance with district policy. Copies of procedures or patient records that do not serve as evidence of a violation should not be collected unless you are directed to do so. Highlighted to denote updated text

Exhibits which include medical records obtained during an investigation or inspection should be handled in accordance with current personal privacy disclosure rules.  Such patient records should remain intact and stored in the official files. When copies of these records are requested internal to FDA, they should be redacted by obliterating the patients full name (keeping first and last initial only), social security number, date of birth, race, personal address and any other personal identifiers. All external requests should be handled by the FOI officer.Highlighted to denote updated text

Submit at least three copies of new or suspect labeling or other material collected as exhibits for labeling purposes. See IOM 4.4.9 for exceptions. These should be mounted in a manner so complete sets are submitted that can be reviewed by individuals in separate offices, i.e., labels 1-10 in each of three sets. You should identify records/exhibits submitted with an EIR using at least the Exhibits' number, firm name, date(s) of the inspection, and your initials. See IOM 5.3.8.2.

 5.10.5.1 - Electronic Information

Electronic information, databases or summary data from databases may be obtained from firms and evaluated during the course of an EI. This data may form the basis for observations or information included in the EIR. It is preferable to include a printed version and/or a summary of the data as an exhibit when received from the firm during an inspection. When it is included as an exhibit to the EIR, it should be stored so as to protect the integrity of the data. See IOM 5.3.8.3.2 for procedures for collecting and identifying electronic data. Electronic media should be protected from extreme temperatures and most magnetic fields. Additional precautions may be necessary and you should be guided by your district procedures for storage of electronic data. See IOM 5.10.4.3.20 Attachments and 5.10.5 Exibits.Highlighted to denote updated text

 5.10.6 - ADDENDUM TO EIR

If your EIR requires correcting or clarification after it has been endorsed , signed and distributed, an addendum may be prepared at the request of your supervisor. The addendum should clearly identify itself with the EIR being added to, explain the necessity for the addendum, and clearly define what section(s) and page(s) are being revised.

Addendums are to be created as a separate document and should not be done in Turbo EIR.

The addendum: will be signed and dated by the preparer and must be endorsed in FACTS by the supervisor.