USFDA inspects the InvaGen manufacturing facility on a regular basis

21 Sep 2023 , 01:13 PM

The United States Food and Drug Administration (USFDA) recently conducted an inspection at the production site of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of Cipla Ltd, the pharmaceutical corporation, on Wednesday, September 20.

According to a stock exchange filing, the facility is situated in Central Islip, Long Island, New York, USA, and the inspection took place between September 11 and September 19, 2023.

This thorough inspection included two essential components: a Pre-Approval Inspection (PAI) intended to assess a site transfer product from InvaGen’s portfolio and a standard Current Good Manufacturing Practises (cGMP) inspection.

InvaGen received a total of 5 inspectional observations in Form 483 after the inspection was finished. It’s significant to note that there were no instances of repeated observations or data integrity (DI) issues.

The USFDA’s observations are crucial steps in ensuring that production procedures adhere to strict quality standards.

InvaGen and its parent company Cipla have reaffirmed their commitment to collaborating closely with the USFDA to fully resolve these findings and do so within the allotted timeframe in response to the observations.

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