FDASIA Section 705 Annual Reports

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).

• 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).
• FDASIA 705 CY 2022 Annual Report on Inspections of Establishments
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• FDASIA 705 CY 2021 Annual Report on Inspections of Establishments
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• FDASIA 705 CY 2020 Annual Report on Inspections of Establishments
  The statutory requirement for publishing this report is May 1st; however, the report was held for release in tandem with the Resiliency Report.
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• FDASIA 705 CY 2019 Annual Report on Inspections of Establishments
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• CY 2018 Annual Report on Inspection of Establishments Report
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• CY 2017 Annual Report on Inspection of Establishments Report
  This year’s report aligns with the statutory charge given by Congress in FD&C Act section 510(h)(6)(C), which changed the reporting requirement from fiscal year (FY) to Calendar Year (CY).
• 2017 Annual Report
• 2016 Annual Report
• 2015 Annual Report
• 2014 Annual Report