The US Food and Drug Administration (USFDA) has completed an inspection at Alembic Pharmaceuticals’ general oral solid formulation facility at Panelav, Gujarat, India. The facility was inspected from October 22, 2018 to October 26, 2018. At the end of the inspection, the US FDA issued a Form 483 with four procedural observations.
The company will provide comprehensive corrective action report to address each observation. The company is committed to maintaining highest quality standards that meet USFDA standards.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.