Question About the Frequency of Unannounced Foreign Inspections, FDA Seems to Be Listening!

Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections.

According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign inspections pilot – which has reportedly been paused – will resume later this year.  The latter assessment was based on a recent comment by FDA Commissioner Martin Makary that foreign firms are ‘held to a much lower inspection standard than US facilities.’”  Given the FDA’s recent rehiring of support personnel to assist in scheduling inspections, obtaining necessary documents like visas and passports, and scheduling travel, and according to Dr. Makary’s statements, it appears that we will soon see an expansion of the pilot, which targeted facilities in India and China, into a full-fledged program that will likely include other countries.

The FDA announcement also states, “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.”

To be sure, the FDA will also use alternate inspectional tools, like remote inspections, when warranted; however, according to Dr. Makary, “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.  That ends today.  This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”

We’ll see how further implementation of the expanded unannounced-inspection program plays out as the FDA begins ramping up surprise inspections.  The best bet for industry domestically and abroad is to be prepared today for an inspection tomorrow should the FDA come knocking on the door; therefore, the time to test your compliance systems is now.  Know that Lachman Consultants is uniquely positioned to assist with all of your compliance needs including resolution of any problems encountered along the way.  Contact us at LCS@lachmanconsultants.com.