FDA Audit Trends, 2023
(Thursday, February 2, 2023)
Last year FDA inspections were down about 20% compared to years prior to 2019, and food facility inspections accounted for more inspections than all other facilities combined. The most common finding at drug and device manufacturing facilities was SOPs not present or not followed. There are a few other important aspects of FDA audits that are available in the annual FDA inspections database for the year 2022. The FDA inspections database is a great resource to understand the kind of issues FDA inspectors find during their audits and help create awareness about these issues so others can address similar issues and prepare better. The database is cumulative across all the years so other than the number and locations of audits each year, one needs to review the data tables to see the current trends. For example, a review of the data tables shows that last year FDA’s enforcement was increased for dietary supplement manufacturers and marketers. Most of the issues identified were related to poor sanitation and lack of safety monitoring practices. The FDA inspections database can be downloaded as Excel worksheet, analyzed for trends, and used for review and update of compliance policies. A useful tool for all compliance professionals.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC