Alembic Pharmaceuticals announced that the U.S. health regulator completed an unannounced inspection of its bioequivalence facility located in Vadodara, Gujarat, and found no observations.
In regulatory documentation, the company stated that the U.S. Food and Drug Administration (USFDA) conducted a bioequivalence on-site inspection from August 31, 2026, to September 10, 2026. The inspection concluded without any Form 483 observations.
According to USFDA terminology, Form 483 is issued to the firm's management following an inspection if investigators discover conditions that may violate the Food, Drug, and Cosmetic Act and related regulations. The absence of observations under this rule indicates a successful inspection outcome.