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U.S. FDA to begin surprise checks abroad
Industry News- May 08,25
The FDA conducts approximately 12,000 domestic and 3,000 foreign inspections annually across over 90 countries.
The U.S. Food and Drug Administration (FDA) will begin conducting unannounced inspections at all foreign facilities manufacturing food, essential medicines, and medical products for the American market. This move expands the agency's Foreign Unannounced Inspection Pilot Programme, which had already been underway in India and China, and is aimed at ensuring regulatory parity between foreign and domestic manufacturers.
Martin A Makary, Commissioner, FDA said, the policy ends the double standard where foreign firms received advance notice of inspections, unlike their American counterparts. The initiative is part of a broader strategy to restore rigorous oversight of global supply chains and improve the credibility of foreign inspections.
The U.S. FDA’s approval is critical for pharmaceutical companies supplying to the U.S., and India, with 650 U.S. FDA-compliant plants, remains the largest base of such facilities outside the U.S. In FY25 (till February), India’s pharma exports to the U.S. grew by 14.29%, reaching nearly $8.95 billion, making the U S the largest market for Indian pharmaceuticals.
The FDA conducts approximately 12,000 domestic and 3,000 foreign inspections annually across over 90 countries. The agency pointed out that despite giving foreign manufacturers advance notice, it found serious violations twice as often as in domestic inspections.
Going forward, the FDA will also revise internal policies to prohibit its investigators from accepting travel accommodations provided by regulated entities, in an effort to enhance the integrity of the inspection process. The agency emphasised that unannounced inspections will help identify and act against bad actors who falsify data or hide violations, protecting American consumers from potential health risks.
(The Hindu)
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