FDA Report on the State of Pharmaceutical Quality

The Report on the State of Pharmaceutical Quality (fiscal year 2024) has been published by FDA's Office of Pharmaceutical Quality (OPQ). The goal is to inform stakeholders about the quality of the U.S. drug supply, analysing FDA-registered drug manufacturers and their CDER-regulated drug products (including biologics). The mission of the Office of Pharmaceutical Quality is to ensure that the U.S. public continues to have access to medicines that meet these standards.

The report compiles both current and cumulative information on manufacturers, products, and identified post-market quality issues. The report also reviews regulatory actions such as recalls, Warning Letters, and import alerts. In addition, it highlights innovative methods being developed to monitor, evaluate, and strengthen pharmaceutical quality.

Warning Letter

• FDA issued 105 Warning Letter to human drug manufacturing sites for reasons related to drug quality.
• Countries with the highest number issued Warning Letter related to drug quality were the U.S. (41), China (13) and India (12).

Import Alerts:

• FDA added 75 sites to import alerts for reasons related to poor drug quality.
• The largest percentage of these import alert additions were associated with sites in China (39%), India (13%), and Europe (13%).
• The majority of sites placed on quality-related import alerts (65% in FY2024 and 90% in FY2023) were manufacturers of OTC products.

Recalls:

• 165 sites generated 260 recall events with 421 recalled products.
• Recalls related to CGMP deficiencies were approximately 24 % (however, in FY2020-FY2023 this defect group represented approximately 50%).
• Countries with the highest number of sites identified as responsible for FY2024 recalls were the U.S. (48%) and India (41%).