Inspections, Compliance, Enforcement, and Criminal Investigations



8-5-1 - 24-Hour Communications System
8-5-2 - Emergency Alerts
8-5-3 - Investigational Instructions
8-5-4 - Emergency Management
8-5-5 - Reporting


8-5-1 - 24-Hour Communications System

Each regional/district office will maintain a means by which headquarters can communicate emergency situations on a 24-hour, 7-days-a-week basis. Each designated contact should be identified, including home phone number, to the EOC. Changes in contact points should be reported in a timely manner to the EOC. Each region/district will establish and maintain procedures for internal communications and provide for appropriate liaison and notification systems to city, county, and state governments, and local offices of Federal agencies.

8-5-2 - Emergency Alerts

All reports of natural or man-made disasters and significant alleged or actual adverse effects associated with FDA-regulated products require prompt reporting to the EOC by phone, but e-mail or fax, text, or other communication methods would be acceptable if phones are not available. Confirmatory or summary reports may be forwarded by Email to or by FAX (301-847-8544). Report the nature and effect of the emergency including as much of the following information as available:

  1. Product description - includes size and type of package; identify manufacturer, lot number, and product code;
  2. Probable or actual distribution pattern, if known, for suspect product(s);
  3. Description of product-related illnesses or injuries, including symptoms, onset times, and duration, where applicable, include name, address, age, sex of affected parties, and identify hospital and medical personnel that are involved, including telephone numbers;
  4. Steps taken to coordinate FDA actions with state, local and other Federal officials. Also, any independent actions taken by state and/or local officials; and,
  5. Actions taken by firms, corrective actions, recalls, or media coverage.

In addition to the above, disasters related to fires, high winds, floods, wrecks, explosions, strikes, civil disorders, covert actions, pandemic influenza, radiological incidents, etc., also require the reporting of:

  1. The magnitude of health hazards or other problems related to FDA activities; and,
  2. The extent to which FDA facilities are or may be affected.

8-5-3 - Investigational Instructions

Refer to IOM, Chapter 8, Investigations, for detailed investigative procedures.

8-5-4 - Emergency Management

  1. Coordination with the EOC

    The Emergency Operations Center will be the focal point for all emergency coordination between the District Office(s) involved, the Center(s) involved, HQ Offices and other federal, state and local agencies. A member of the EOC staff will be designated to oversee each emergency situation. However, all EOC staff members are kept abreast of the situation and should be able to serve as a backup, as necessary.

    Other Offices and Agencies involved in an emergency situation will identify a contact for all communications.

  2. Lead District

    As FDA conducts response operations under ICS, the district in which the emergency is occurring (e.g., where people are becoming ill or where a disaster has occurred), will assume the lead investigative role in determining the cause of the emergency, managing on-scene operations, and obtaining necessary information for the agency to confirm the health hazard.

    If it becomes apparent during the course of the investigation that a firm in another district is responsible for the product involved in the emergency, the "lead district" designation will be transferred to the home district of the responsible firm.

    Any change in the designation of "lead district" should be concurred with by the EOC.

    In certain widespread emergencies involving more than one responsible firm, the EOC may assume the lead role without designation of a "lead district."

    The "lead district" will identify an ad hoc emergency management team to be headed by the District Director or a designated district person and a coordinator. The exact number and mix of persons on the team will be determined by the district. Any recommendations for reallocation of field staff between or among districts during emergencies should be directed to the Office of Regional Operations (ORO).

  3. District Emergency Coordinator

    A senior staff employee should be promptly named as coordinator of the emergency response activities. This person should generally be located at the lead district office to facilitate communication and record review. In a widespread emergency, additional coordinators may be named by the involved districts as necessary. The coordinator will be responsible for advising management of actions needed to follow-up on the emergency and channeling all necessary communications.

    Any or all of the following steps should be included:

    1. Investigation/Analysis
      1. Issuing assignments to district personnel to obtain the information necessary for Agency personnel to evaluate the health hazard of the situation;
      2. Monitoring assignments to assure timely completion;
      3. Arranging for continuing contact with investigators for flow of information;
      4. Seeking technical guidance through the EOC relating to the investigation, samples needed, etc.; and,
      5. Determining in consultation with Division of Field Science, ORA the appropriate laboratory to submit samples to and alerting that laboratory as soon as possible so that necessary preparations may be made.
    2. Maintaining Communications
      1. Keeping appropriate District and Regional management informed of investigational and analytical progress;
      2. Preparing daily status reports;
      3. Contacting the appropriate state and local authorities already involved with the investigation; and,
      4. Serving as local FDA press contact concerning the emergency. The coordinator or other designated official will work with headquarters in preparing statements to the press.

        NOTE: FDA field and headquarters employees may be asked to respond to media inquiries about ongoing investigations when not in a position to first seek guidance from the Office of Public Affairs (OPA). Such employees must assess these situations and the media requests on an individual basis and respond appropriately. When possible, media requests should be referred to first line supervisors or above. Unless specifically authorized to do so, only those employees whose position descriptions include communications with the press should provide statements to the press.

        Care must be taken to ensure that timely, accurate, complete and authorized information is issued.

        Significant emergency press coverage should be reported to EOC promptly. EOC will notify the Office of the Commissioner, OPA, DFSR and other offices of the press coverage. Copies of local press releases by the state and/or the firm should be faxed as soon as possible to EOC.

    3. Documentation
      1. A chronology of the emergency situation should be kept, starting with the original alert. It should be updated frequently since this information is often needed on short notice by Agency or Department personnel.
      2. Significant telephone conversations involving the emergency should be documented (by the participants) and forwarded to EOC daily.
      3. Statistical data such as numbers of samples analyzed, inspections made, injuries reported, farms quarantined, etc., should begin early in the process and be maintained.
  4. Location of Field Command Post

    The FDA lead district office (or a large resident post) facility should generally serve as FDA's field command post because of the available communications equipment. If the emergency is in a state without a well equipped FDA office, consideration may be given to locating FDA's field command post at the cooperating lead state agency.

8-5-5 - Reporting

  1. Status Report

    During the height of an emergency, the district's emergency coordinator should forward daily status reports by E-mail or FAX (301-847-8544) to the EOC with a copy to the responsible emergency coordination unit for the center(s). Copies of such reports should also be forwarded to the "lead districts" by all investigating districts. The EOC will specify when status reports are needed less frequently. Status reports should be in bullet format, highlighting significant information concerning the emergency (e.g., investigations, analyses, public affairs, cooperating agencies, scientific, and court matters).

    The EOC will facilitate contact between districts with the appropriate center coordinator.

  2. Hard Copy Reports

    Copies of all reports pertaining to the initial alert and subsequent investigation should be forwarded to the responsible center(s) and to the EOC. Each submission must include product name and product code to enable proper filing by the EOC. Copies of complaint reports, memos, collection reports, establishment inspection reports, reports of analyses, follow-up investigations, recommendations for regulatory action and/or recalls, when generated by an emergency, should be submitted. Unless a specific center office is identified to receive hard copy, hard copy reporting to the centers for emergencies is as follows:

    1. CFSAN Food and Drug Administration

      Center for Food Safety and Applied Nutrition
      Office of Food Defense, Communication and Emergency Response
      Supervisor, Emergency Coordination and Response Team (HFS-015)
      5100 Paint Branch Parkway, Room 2B-014
      College Park, MD 20740-3835

    2. CDER Food and Drug Administration

      Center for Drug Evaluation and Research
      Office of Counter-Terrorism & Emergency Coordination
      10903 New Hampshire Avenue
      Building 51, Room 3342
      Silver Spring, MD 20993

    3. CBER Food and Drug Administration

      Center for Biologics Evaluation and Research
      Office of Compliance and Biologics Quality (HFM-650)
      Division of Inspections and Surveillance
      1401 Rockville Pike
      Rockville, MD 20852-1448

    4. CDRH Food and Drug Administration

      For all reports:

      Center for Devices and Radiological Health
      Office of Compliance
      10903 New Hampshire Avenue
      Building 66
      Silver Spring, MD 20993

      For reports of incidents involving radiation or radioactive material releases:

      Center for Devices and Radiological Health
      Office of Communication, Education and Radiation Programs
      Division of Mammography Quality and Radiation Programs
      10903 New Hampshire Avenue
      Building 66, Room 4676
      Silver Spring, MD 20993

    5. CVM Food and Drug Administration

      Center for Veterinary Medicine
      Office of Compliance and Surveillance
      Division of Compliance (HFV-230)
      Metro Park North 2, Building #4
      7519 Standish Place
      Rockville, MD 20855

    6. CTP Food and Drug Administration

      Center for Tobacco Products
      Office of Compliance and Enforcement
      Enforcement and Manufacturing
      9200 Corporate Blvd
      Rockville, MD 20850

    7. Food and Drug Administration

      Emergency Operations Center, OCM/OC
      10903 New Hampshire Avenue
      Building 32, Room 1359
      Silver Spring, MD 20993

  3. Final Reports

    When the investigation of any emergency, (e.g., disaster, or civil disorder) has been terminated, the lead district will submit a final written summary to OC/OCM/EOC with a copy to the responsible center emergency coordination unit. This summary will be prepared from previous reports, records of meetings, chronologies, and reports from cooperating officials.


Page Last Updated: 05/02/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English