The U.S. Food and Drug Administration (FDA) is stepping up its use of unannounced inspections at foreign manufacturing facilities that produce medicines and other medical products.
According to a press release, the FDA currently conducts about 12,000 domestic facility inspections and 3000 foreign facility inspections each year, covering more than 90 countries around the globe. However, U.S.-based manufacturing facilities are typically inspected without prior notice, while foreign-based facilities are usually given advanced notice of plans for inspections.
The FDA says that these different inspection protocols give foreign-based facilities ample time to prepare for their inspection and provide a theoretical advantage over domestic facilities in the FDA’s oversight process. It also provides those facilities with an opportunity to falsify records or find ways to conceal potential violations of FDA requirements ahead of the actual inspection.
Going forward, the FDA says it plans to expand its use of unannounced inspections to include foreign-based facilities as well. These steps will “provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”
The FDA’s press release about its expanded use of unannounced facility inspections is available at https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities.
