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# Drug Quality Assurance Inspections Up in 2025
- URL: https://www.fdaweb.com/drug-quality-assurance-inspections-up-in-2025/
- Published: 2026-06-25T12:00:00.000Z
- Updated: 2026-09-14T13:41:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161380

The FDA FY 2025 *Report on the State of Pharmaceutical Quality* shows that in FY 2025, there were 1,248 drug quality assurance inspections, up from 972 such inspections in FY 2024\. Of the 1,248 drug quality inspections, 432 (44%) were in the U.S., and 540 (56%) were in foreign countries.

At the end of FY 2025, the report says, CDER’s Site Catalog included 5,953 manufacturing sites globally, with 57% of them located in the U.S.

CDER’s Product Catalog contained 422 BLAs, including 82 biosimilar products, a 30% increase from the 63 biosimilar products at the end of FY 2024.

The report says that BLAs have increased from 2.3% of all approvals in FY 2016 to 4.8% in FY 2025, with biosimilars representing 42% of the approved BLAs in FY 2025, up from 17% in 2016.