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