USFDA Inspection Yields Five Observations at Alembic's Gujarat Plant

Alembic Pharmaceuticals faced a USFDA inspection resulting in a Form 483 with five procedural observations at its Gujarat-based plant. The company plans to respond comprehensively to these findings within the required timeframe.

The US health regulator, the US Food and Drug Administration (USFDA), has flagged five procedural observations at Alembic Pharmaceuticals' manufacturing facility in Gujarat. This follows an inspection that took place at the plant located in Jarod from November 14-22, 2024.

Alembic Pharmaceuticals confirmed that a Form 483 was issued, which typically denotes areas where the company needs to align with regulatory standards. These observations highlight aspects that require the company's immediate attention to comply with USFDA guidelines.

The pharmaceutical company announced its intention to issue a comprehensive response addressing the USFDA's concerns within the stipulated period, aiming to resolve the procedural issues cited during the inspection.

(With inputs from agencies.)