FDA announces expanded use of unannounced inspections at foreign facilities

The U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change 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. In addition, the FDA said it 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, to maintain the integrity of the oversight process. 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. “But regulated companies do not have the authority to negotiate the day or time of the inspection–nor should foreign companies have the capability to do so either,” the agency said.