The Food and Drug Administration is expanding the use of unannounced inspections at foreign facilities that produce foods and medicines, building on a pilot program already used in India and China.
The agency also is planning to update its policies for FDA investigators to refuse travel and lodging provided by regulated companies.
“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,” FDA Commissioner Martin A. Makary says in a press release.
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The agency conducts more than 3,000 foreign inspections annually.
Domestic inspections are preannounced only to ensure the needed personnel and records are available, the agency says.
“While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process,” the FDA release says. “Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.”
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