Gets 4 procedural observations under Form 483
New Delhi: Alembic Pharma through a recent regulatory filing announced that the United States Food and Drug Administration (US FDA) has completed an inspection of its general oral solid formulation facility at Panelav, Gujarat, India. This was a scheduled pre-approval inspection carried out from 22nd October, 2018 to 26th October, 2018 and 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.