US FDA issues form 483 to Alembic Pharma’s Panelav facility for oral solids

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update filed to the Indian Bourses on Friday, Alembic Pharmaceuticals Ltd said of having got their Panelav facility manufacturing general oral solids inspected by US FDA (Food & Drugs Administration) and the regulator having slammed Form 483 to the facility, after inspection.

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 26 1h October, 2018 and at the end of the inspection, the US FDA issued a Form 483 with four procedural observations.

According to the USFDA website, Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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.

Announcement from the company had hit the exchanges, just few minutes prior to closing of trading session on the Indian Bourses over a weekend, resulting some sentimental improvement into the share price of the company, which ended in GREEN Zone on positive counters on Friday, when trading session on the Indian Bourses ended.