USFDA Issues Form 483 to Alembic Pharmaceuticals with One Observation

The USFDA conducted an inspection at Alembic Pharmaceuticals' Bioequivalence Facility in Vadodara from March 3 to 7, 2025. Following the inspection, a Form 483 was issued with one procedural observation. Alembic Pharmaceuticals has committed to addressing this observation and will submit a comprehensive response within the stipulated timeframe. This proactive approach underscores the company's commitment to quality and regulatory compliance. The inspection highlights Alembic's ongoing efforts to maintain high industry standards in its operations.

 

Sources: Business Standard, Business Upturn, Alembic Pharmaceuticals Official Statement