What US FDA’s new surprise foreign inspections plan means for India

On May 06, 2025, the US Food and Drug Administration announced the expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. The release mentions that this change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot programme in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.

The revival of unannounced inspections of overseas manufacturing plants will need considerable planning at the US FDA. But any hopes of lower oversights due to the recent staff cuts at the US FDA, as part of the Trump Administration’s reduction in force (RIF) efforts, were dashed by recent reports that the agency plans to rehire some staff providing logistics support for the inspections programme. 

This should be taken as a signal of the agency’s intention to revive overseas inspections as soon as possible. Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory-gate.” 

The release also notes that the FDA is authorised to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection. 

This policy move seems to be aimed at addressing a key grouse of US-based manufacturers: that their foreign counterparts get advance notice of inspections, allowing them an undue advantage to set the stage. This is evident in DA Commissioner Martin A. Makary’s statement that, “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.” 

As per the FDA release, the agency conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. The May 6 announcement evidently seeks to rebalance this skew in the number of inspections across jurisdictions. 

The release further points out that while US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections, as per the release.

The US FDA does make exceptions allowing preannounced domestic inspections “in specific programmes and cases”, “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.” 

Besides expanding overseas inspection programme, the US FDA seems to be revamping certain processes. The release notes that “the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include 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.” Thus the agency’s intention to tighten the loopholes is very evident.

The release ends almost on a warning note, that this expanded approach “marks a new era in FDA enforcement—stronger, smarter, and unapologetically in support of the public health and safety of Americans.”

Many larger Indian pharma companies seem to have read the writing on the wall and have initiated collaborations with US-based counterparts or indicated increased investments in their own US presence. For instance, in March, Syngene International acquired its first biologics manufacturing site in the US. In the same month, Sun Pharma acquired New York City-based Checkpoint Therapeutics, an immuno-oncology biopharmaceutical company focussing on solid tumors. Companies with a manufacturing presence in the US are buying assets to leverage this presence. For instance, in May, Senores Pharmaceuticals acquired USFDA-approved Abbreviated New Drug Application (ANDA) for Enalapril Maleate Tablets 2.5mg, 5mg, 10mg, and 20mg from Wockhardt, a move aimed at expanding Senores’ portfolio in the US market. 

While business strategies could help in the short term, it is clear that companies seeking a slice of the US market will need to comply with higher US FDA benchmarks. Being inspection ready at all times will need to be the default protocol. This policy change comes against the backdrop of President Trump’s tariff regime. Various countries, including India are currently negotiating bilateral trade deals to limit the impact of tariffs. While heightened regulatory scrutiny might well be an intended entry barrier and a bargaining chip in ongoing trade negotiations, pharma companies would do well to buckle down and toe the line.

VIVEKA ROYCHOWDHURY, Editor
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