U.S. FDA to inspect sans notice all foreign manufacturing food, drug, medical products for America 

The U.S. Food and Drug Administration (U.S. FDA) has decided to inspect unannounced all foreign facilities manufacturing food, essential medicines and other medical products for American consumers and patients.

The move builds on the agency’s office of Inspection and Investigations Foreign Unannounced Inspection Pilot programme in India and China. It is aimed to ensure foreign companies receive the same level of regulatory oversight and scrutiny as domestic companies, U.S. FDA said on Tuesday.

“For too long, foreign companies have enjoyed a double standard — given advance 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,” FDA Commissioner Martin A. Makary said in a statement.

U.S. FDA inspection and approval of the facilities is crucial for pharma firms, both aspiring to and already supplying to the U.S. In India, there are 650 U.S. FDA compliant plants, the largest outside the U.S., according to a recent Bain & Company report.

The U.S. is the largest market for Indian pharma accounting for one-third of the total pharma exports. For 11 months ended February, pharma exports to the U.S. rose 14.29% to $8953.37 million ($7833.75 million). India’s total pharma exports in FY25 increased 9.39% to $30467.32 million. Granular details of the exports in March is not yet public.

The U.S. FDA said it will also evaluate the policies and practices for improvements to the foreign inspection programme. The changes will include clarifying policies for its 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. The U.S. FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections every year in more than 90 countries.

While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite advance warning to foreign firms, serious deficiencies were found to be twice as often compared to domestic inspections, the regulator said.

Only in specific programmes and cases are domestic inspections pre-announced as a step to ensure that appropriate records and personnel are available during the inspection. Unannounced inspections will also help expose bad actors — those who falsify records or conceal violations—before they can put American lives at risk, it said.

Sources in Indian pharma industry, however, said not all U.S. FDA inspections are unannounced. While some are surprise inspections, there are also those undertaken at periodic intervals. For long, the pharma companies have been underscoring the need for U.S. FDA to intimate in advance and inspect.

According to the report, India has more than 10,000 manufacturing facilities of over 3,000 pharma companies. It is the largest supplier of generic medicines globally, supplying one in five generic drugs sold.