The Food and Drug Administration (FDA) said yesterday that it plans to expand unannounced inspections at foreign sites that produce food, essential medicines, and other medical products for US consumers, a move agency officials say will ensure that foreign companies receive the same level of oversight as US companies.
The FDA conducts an estimated 3,000 foreign inspections each year in more than 90 countries, but foreign firms get advanced warning and often have weeks to prepare for the inspections, which agency officials say undermines the inspection process. In contrast, the FDA's 12,000 annual inspections of domestic food and drug manufacturing sites are pre-announced only in specific programs and cases.
Despite the advanced warning, the FDA said, serious deficiencies were found more than twice as often in foreign manufacturing sites as domestic sites.
Ending the 'double standard'
FDA Commissioner Martin Makary, MD, MPH, called the move a "key step" in a broader strategy to get foreign inspections back on track.
"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," Makary said in an FDA press release. "That ends today."
The FDA said it will also evaluate its policies and practices to find other ways to improve the foreign inspections program and maintain the integrity of the oversight process. Among the changes will be clarifying policies for FDA investigators to refuse travel accommodations from regulated industries.