FDA Will Increase Unannounced Inspections at Foreign Manufacturing Facilities
The FDA on May 6 said it intends to increase unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients – “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”
The change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China. In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight.
“These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry, including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process,” an agency statement said.
“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,” said FDA Commissioner Martin Makary. “That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”
In addition to 12,000 domestic inspections, the FDA conducts approximately 3,000 foreign inspections each year in more than 90 countries. Only in specific programs and cases are the FDA’s domestic inspections pre-announced to assure that appropriate records and personnel will be available during the inspection.
“While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process,” the statement said. “Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.”
The FDA is authorized to take regulatory action against any firm that seeks to delay, deny or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.
