Alembic Pharma Gets US FDA Form 483, 4 observations at Gujarat facility

Alembic Pharmaceuticals said on Saturday that the US Food and Drug Administration issued a Form 483 with four observations following an unannounced routine inspection of its active pharmaceutical ingredient-I and II facility in Panelav, Gujarat, between May 26 and May 31.

The company said none of the observations relate to data integrity and management believes they can be addressed. Alembic plans to submit a comprehensive response within the stipulated period.

The company reaffirmed its commitment to maintaining the highest quality standards and compliance at all times.