WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced plans to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products for American consumers and patients.
This move builds upon the agency's Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies, FDA said in a press release.
'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.
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process, according to FDA.
Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections, it said in a press release.
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