The FDA said it plans to expand the use of unannounced inspections at foreign manufacturing facilities.
The agency said it intends to inspect facilities producing foods, essential medicines and medical products intended for American consumers and patients. The change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China, according to a news release. FDA says it wants to ensure foreign companies receive the same level of regulatory oversight and scrutiny as domestic companies.
Additionally, the agency plans to evaluate policies and practices for improvements to its foreign inspection program. That includes clarifying policies for FDA investigators to refuse travel accommodations from regulated industry lodging and transportation arrangements “to maintain the integrity of the oversight process.” It listed taxi, limousine and for-hire vehicle transit among those accommodations.
The FDA says it conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent unannounced inspections, the agency says, but foreign firms “have often had weeks to prepare.”
“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,” FDA Commissioner Dr Martin Makary said in the release. “That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.” Medical Design & Outsourcing