US FDA: Expanded use of unannounced inspections outside of the USA
- Date
- May 6, 2025
- Category
US Regulations
- Description
On 6 May 2025 the FDA announced their intention to expand the use of unannounced inspections at foreign manufacturing facilities. This will build upon the Office of Inspection and Investigations (OII) existing pilot of unannounced inspections in India and China, which was initiated in India in March 2022 and in China in July 2023. By May 2024, May 2024, the FDA had conducted 114 pilot inspections in India, including 94 that were unannounced, and 28 in China, 16 of which were unannounced. This recent announcement means that FDA will now be conducting unannounced inspections in many other countries.
When making this announcement, FDA Commissioner Martin A. Makary, said:
“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,”
The FDA will also said that they will evaluate their policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight.
Read more : FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities