Wednesday, 25 April 2018

Audit report: USFDA finishes inspection at Alembic Pharma’s Panelav plant- Zero 483 observations

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Drug major Alembic Pharmaceuticals on Tuesday said the US health regulator has conducted an inspection at its Panelav facility and has not made any observations.

“The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Panelav from April 16-23, 2018. This was a scheduled inspection and at the end of the inspection, there were zero 483s,” Alembic Pharmaceuticals said in a BSE filing.
An FDA Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related acts. It notifies the company’s management of objectionable conditions at a facility.
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