FDA to perform more unannounced inspections at foreign manufacturing facilities

May 9, 2025

The U.S. Food and Drug Administration (FDA) will begin examining certain foreign manufacturing facilities without prior notice, according to an announcement.

The goal of this action is to make sure these facilities “receive the same level of regulatory oversight and scrutiny as domestic companies.” The companies that will undergo inspections “produce foods, essential medicines, and other medical products intended for American consumers and patients.” The FDA is also seeking to enhance their inspection process by “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.”

FDA announcement

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