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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PART V - REGULATORY / ADMINISTRATIVE STRATEGY

  1. District EIR Classification Authority
  2. The District is encouraged to review and initially classify EIRs under this compliance program.
  3. Center EIR Classification Authority
  4. The Center has the final classification authority for all Bioresearch Monitoring Program inspection reports. The Center will provide to the District copies of all final classifications, including any reason for changes from the initial classification.
  5. EIR Classifications
  6. The following guidance is to be used in conjunction with the instructions in FMD-86 for initial District and Center classification of EIRs generated under this compliance program:

    1. NAI - No objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
    2. VAI - Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
    3. OAI - Regulatory and/or administrative actions will be recommended.
  7. Post-Inspectional Correspondence
  8. Under the BIMO program the Centers are responsible for administrative or regulatory follow-up. The District Office should advise the Center of any response to the FDA 483 or any other communication (written or oral) with the facility concerning the inspection. Similarly, if the Center has communication with the facility following the inspection the District should be advised of such communication.
  9. District Follow-up
  10. All District follow-up action, including reinspection, will be made at the request of the Center. On occasion, District compliance units may initiate case development activities and may issue investigative assignments whenever review of the inspection report raises the possibility of severe violations of the FFD&C Act or other Federal statutes. This intention is to be immediately communicated to the Bioresearch Monitoring Program Coordinator (HFC-230).
  11. Regulatory/Administrative Actions
  12. The regulatory/administrative actions that can be used under this compliance program are not mutually exclusive. Follow-up of an OAI inspection may involve the use of one or more of the following:

    1. Warning Letter
    2. Re-inspection
    3. Informal conference
    4. Third party validation of a nonclinical study or studies
    5. Rejection of a nonclinical study or studies
    6. Disqualification of the facility
    7. Injunction/prosecution
    8. Withholding or revocation of marketing permit
    9. Termination of a research permit
    10. Application integrity policy