USFDA inspection at Vadodara facility completed with no observations
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Alembic Pharmaceuticals announced that the USFDA completed an unannounced onsite bioequivalence inspection at its Vadodara, Gujarat facility from August 31 to September 10, 2026. The inspection was closed with no Form 483 observations, indicating compliance with US regulatory standards. A clean outcome supports the company's ability to continue supplying products to the US market.
Positive: clean USFDA inspection with zero observations strengthens US market access and regulatory credibility.