FDA: 2024 Report on the State of Pharmaceutical Quality

According to the report, FDA’s catalog listed 4,619 manufacturing sites worldwide, 41% of which are based in the United States. Inspection activity continued to rise, with 972 drug quality assurance inspections, a 27% increase from FY2023, and a record 198 inspections conducted under Mutual Recognition Agreements (MRA). More than 62% of inspections were carried out at foreign sites – the highest share to date.

The FDA’s product catalog also expanded, now including 14,168 Abbreviated New Drug Applications (ANDAs), 3,625 New Drug Applications (NDAs), and 383 Biologics License Applications (BLAs), with biosimilars increasing by 47% compared to FY2023. Postmarket quality defect reports decreased slightly to 16,837, with fewer Field Alert Reports but more Biological Product Deviation Reports.

Regulatory actions included 75 new import alerts, mostly for OTC manufacturers (65 %). The largest percentage of these import alert additions were associated with sites in China (39%), India (13%), and Europe (13%).

421 products were recalled, the lowest in five years. Recalls related to CGMP deficiencies represented 24% of the recalls – in contrast to 50% for FY2020-FY2023. Countries with the highest number of sites identified as responsible for FY2024 recalls were the U.S. (48%) and India (41%).

At the same time, FDA issued 105 warning letters, the highest number since FY2019, driven by intensified inspections. The countries with the highest number of warning were the US (41), China (13), and India (12).

Source:

FDA: CDER/Report on the State of Pharmaceutical Quality