The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report.

For fiscal year 2023 — Oct. 1, 2022 through Sept. 30, 2023 — the FDA conducted a total of 2,953 CGMP inspections at 902 foreign and 2,051 domestic facilities.

This compares with a total of 2,442 inspections, including 381 foreign and 2,061 domestic inspections reported for calendar year 2022, indicating that foreign inspections more than doubled in fiscal 2023 while domestic inspections remained at the 2022 levels.

The agency switched from calendar year to fiscal year reporting for 2023, so the latest inspection numbers are not exactly comparable to those in previous annual reports, although they indicate a significant spike in foreign inspections. Lawmakers mandated the change to fiscal year reporting of inspections in the Food and Drug Omnibus Reform Act of 2022.

To get back to pre-pandemic levels of inspections, the FDA would need to conduct more than 1,000 additional inspections. Prior to the onset of the pandemic, the agency conducted 1,200 foreign and 3,139 domestic inspections for a total of 4,339 in calendar 2019.

The 2023 report includes a breakdown of inspections by “region of interest,” with 155 inspections conducted in India, 53 in China, 287 in the European Union, 38 in the United Kingdom and 369 in the rest of the world. [FDAnews]