The United States Food and Drug Administration (US FDA) conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' solid oral formulation facility (F-4) located at Jarod in Gujarat.

The USFDA issued Form 483 with five procedural observations. None of the observations is related to data integrity and management believes that they are addressable.

The company is preparing the response to the observations, which will be submitted to the USFDA within a stipulated period.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.