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USFDA set to increase 'unannounced inspections' at foreign manufacturing facilitiesThe USFDA's move, building on a pilot programme in India and China, seeks to eliminate the double standard where foreign firms often received advance notice of inspections—unlike their US counterparts who routinely face surprise checks.By Ekta Batra   May 7, 2025, 11:29:47 AM IST (Published)2 Min ReadIn a significant shift aimed at tightening oversight, the US Food and Drug Administration (FDA) has announced it will expand the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers.

This move, building on a pilot programme in India and China, seeks to eliminate the double standard where foreign firms often received advance notice of inspections—unlike their US counterparts who routinely face surprise checks.

The FDA conducts around 15,000 inspections annually, with 3,000 of those at foreign sites. Despite prior notice, foreign facilities have historically shown more serious deficiencies than US plants. With this new approach, the FDA aims to uncover violations in real time and take swift action against companies that attempt to delay, obstruct, or refuse entry for inspections.

The agency is also tightening its internal policies by prohibiting investigators from accepting industry-paid lodging or transport to uphold impartiality.

Indian pharmaceutical companies, which form a large part of the US generic drug supply chain, are closely watching this development.

Shaunak Amin, Managing Director of Alembic Pharmaceuticals, welcomed the FDA’s decision. Companies that see regular inspections state that the increased scrutiny is a step in the right direction to ensure global quality standards.

However, analysts at Nuvama warned that the move could pose challenges for Indian firms already struggling with compliance—especially those with data integrity issues. Unannounced inspections may expose ongoing gaps and could lead to regulatory setbacks.

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