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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PART VII – HEADQUARTER’S RESPONSIBILITIES

  1. Office of Regulatory Affairs
    1. Division of Compliance Policy (HFC-230)
      1. Coordinates compliance policy and guidance development.
      2. Coordinates responses to inquiries regarding agency interpretation of regulations and policy.
      3. Serves as the liaison with other Federal agencies and foreign governments with whom FDA has Memoranda of Agreement or Memoranda of Understanding.
      4. Resolves issues involving compliance or enforcement policy.
      5. Advises and concurs with Centers on recommended administrative and regulatory actions.
      6. Coordinates the distribution and review of multi-center and inter-agency EIRs including the planning, coordination, and designation of a lead Center for EIR classification, issuance of correspondence, and follow-up assignments.
      7. Coordinates Center and other Federal agency inspection assignments.
      8. Coordinates modifications and future issuances of this compliance program.
      9. Prepares notice of first inspection letters to university and government laboratories.
    2. Division of Emergency and Investigational Operations (DEIO; HFC-130)
      1. Provides inspection quality assurance, training of field personnel, and operational guidance.
      2. Maintains liaison with Centers and Field Offices and resolves operational questions.
      3. Coordinates and schedules joint Center and multi-District inspections.
    3. Division of Field Science (DFS; HFC-140)
      1. Assigns laboratories for sample analysis and responds to method inquiries.
  2. Centers
    1. Review EIRS and regulatory/administrative recommendations forwarded by the districts.
    2. Provide OE with a list of facilities on a quarterly basis, or as other priorities dictate, to be scheduled for inspection.
    3. Select studies to be audited and provide necessary support documents.
    4. Prepare letters for issuance by the Center, ORA, or Commissioner as appropriate.
    5. Issue all assignments to the field.
    6. Recommend compliance program changes to OE.
    7. Distribute copies of EIR correspondence to districts and OE.
    8. Provide inspectional support to the field by direct participation and in consultant capacity.
    9. Copy all Centers whenever a Warning Letter has issued to a specific laboratory.