Alembic Pharmaceuticals said that US health regulator has conducted an inspection at it Panelav facility in Gujarat and issued Form 483 with four procedural observations.
“The US Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020,” the drug firm said in a filing to the BSE.
This was a scheduled inspection, and at the end of the inspection, the US FDA issued a Form 483 with four procedural observations.
None of the observations are related to data integrity or repetitive in nature.
“The company will provide comprehensive corrective action report to address each observation. The company is committed to maintaining highest quality standards that meet US FDA standards,” it said.
The US health regulator issues observations by means of a FDA Form 483 notifying the company’s management of objectionable conditions at the facility inspected.