FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot

By Sarah Fitzgerald and Evangeline Loh

The U.S. Food and Drug Administration (FDA) has announced (May 6) that the Office of Inspections and Investigations (OII) will expand its program (pilot) of unannounced inspections beyond India and China.

As we reported earlier this year, the FDA has the authority to perform both announced and unannounced inspections. In general, inspections of relevant entities in the U.S. have been unannounced while inspections of relevant entities outside the U.S. have been pre-announced, usually several weeks before the inspection and providing multiple options. In theory, this helps to confirm that the entity will be actively manufacturing products during the inspection.

The FDA started performing unannounced inspections in India and China and is now expanding unannounced inspections to other foreign entities.

Counting all regulated products (food, drugs, biologics, and medical devices), the FDA performs 12,000 domestic inspections and 3,000 foreign inspections.  

Following an inspection, the FDA classifies the inspection into one of three categories: no action indicated (NAI), voluntary action indicated (VAI) and official action indicated (OAI). An inspection finding of NAI or VAI can result in the issuance of a FDA Form 483. This data is available on the Compliance Dashboard.

Expansion to all foreign manufacturing facilities

This recent announcement is a significant change in policy as it treats all manufacturing facilities of foods, drugs, biologics and medical devices as equal. According to FDA Commissioner Martin A. Makary, M.D, M.P.H.  this initiative forms “part of a broader strategy to get foreign inspections back on track.”

Simultaneously, the FDA will assess its policies related to its foreign inspection program for improvements, clarity and integrity.

Medical Device Single Audit Program (MDSAP)

It is important to note that there are no changes to MDSAP audits being accepted in place of routine FDA inspections at this time. For medical device manufacturers outside the U.S., this may be a valuable option to consider.

Concluding remarks

The FDA signals this as an advancement to establish itself as the “gold standard for regulatory oversight.”

This also further aligns with recent  European policy. The European legislation (Directives and Regulations)  has always permitted unannounced audits of medical device manufacturers, though this has become more evident after the nefarious actions of the PIP manufacturer of breast implants.