FDA-TRACK: Annual Reports on Inspections of Establishments
Section 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on its website reports on inspections of establishments registered under section 510 of the FD&C Act. Following minor amendments to section 510(h)(6) by section 3101(a)(2)(H) of the 21st Century Cures Act (Public Law 114-255) and section 901(e) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), the reporting requirements under section 510(h)(6) (“Annual Report on Inspections of Establishments”) of the FD&C Act were more substantially amended on December 29, 2022, by section 3616(c) of the Food and Drug Omnibus Reform Act of 2022 (FDORA) (title III of division FF of Public Law 117-328).
Annual performance reports are prepared by FDA’s Performance Management Staff (PMS) in collaboration with the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Center for Veterinary Medicine, and the Office of Inspections and Investigations.
- FY 2024 Annual Report on Inspections of Establishments
This year’s report aligns with the statutory charge given by Congress in section 3616(c) of the Food and Drug Omnibus Reform Act of 2022 (FDORA) (title III of division FF of Public Law 117-328). - FY 2023 Annual Report on Inspections of Establishments
This year’s report aligns with the statutory charge given by Congress in section 3616(c) of the Food and Drug Omnibus Reform Act of 2022 (FDORA) (title III of division FF of Public Law 117-328).