The FDA is stepping up its unannounced inspections of foreign manufacturing facilities.
In a statement about the increase in inspections, the Food and Drug Administration did not report how many inspections will be conducted. It is unclear how the number of inspections will be impacted by recent staff cuts at the agency
The change incudes facilities that produce food, in addition to producers of medicine and other medical products. The vast majority of the FDA’s budget goes to fund the drug side of the agency.
FDA officials say making more unannounced inspections will bring the agency’s handling of foreign producers more in line with inspections of U.S. facilities.
Annually, the FDA conducts about 12,000 inspections at U.S. manufacturers of food, medicine and other medical products. There are more than 100,000 food plants in the United States. The agency inspects about 3,000 foreign inspections across 90 countries annually.
Domestic inspections are pre-announced in specific programs and cases to allow personable time to gather records necessary for the inspections. Unlike foreign companies, U.S. firms are not allowed to negotiate the day or time of inspections.
“For too long, foreign companies have enjoyed a double standard — given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary.
In addition to increasing the number of unannounced inspections for foreign facilities, the FDA will evaluate its policies and practices to ensure that the agency is the “gold standard” for regulatory oversight, according to the FDA announcement. Possible changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated companies including lodging and transportation arrangements to maintain the integrity of the oversight process. This will increase the FDA’s cost of the inspections.
The increase in foreign inspections is designed to help expose companies who falsify records of conceal violations, according to FDA Assistant Commissioner for Inspections and Investigations Michael Rogers.
Every foreign inspection goes through a classification assignment process to enable an appropriate regulatory response. Inspections that yield a “No Action Indicated” status provide important regulatory intelligence that strengthens the safety net for American consumers, according to the FDA’s announcement.
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