FDA-TRACK: Compliance Inspection Activities

 

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FDA-TRACK: OII Dashboard

The Office of Inspections and Investigations (OII) serves as the lead office for all FDA field inspection, investigation, imports, and emergency response activities. OII reports compliance inspection performance measures that track follow-up actions on significant violations and firms' movement toward compliance to ensure food, feed, and medical products are safe and effective for the American public.

FDA-TRACK: Inspections of Establishments Performance

Section 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on inspections of establishments registered under section 510 of the FD&C Act. Establishments registered under Section 510 of the FD&C Act engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs, human biologics regulated as drugs, and devices.

FDA-TRACK: FDARA Section 902 Inspections Performance

Section 902 of the FDA Reauthorization Act (FDARA) requires FDA to publish annual reports on inspections of facilities necessary for approval of a drug or a device conducted during the previous fiscal year.

FDA-TRACK: GDUFA Performance

The Generic Drug User Fee Amendments (GDUFA) authorizes FDA (specifically CBER and CDER) to assess and collect fees for generic drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of generic human drug applications to ensure patients have access to safe, high-quality, and affordable generic drugs.