The inspection concluded with no Form 483 observations (Photo: Company website)
Alembic Pharmaceuticals on Friday said the US health regulator has completed an unannounced inspection at its bioequivalence facility in Vadodara, Gujarat, with zero observation.
In a regulatory filing, the company said the United States Food and Drug Administration (USFDA) carried out the onsite bioequivalence inspection from August 31, 2026, to September 10, 2026.
The inspection concluded with no Form 483 observations, it added.
In USFDA parlance, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when investigators observe conditions that may violate the Food, Drug, and Cosmetic Act and related regulations. No observations under this rule indicate a clean outcome.