Cipla's InvaGen Pharma Receives Positive USFDA Inspection Report

12 Oct 2023 , 11:49 AM

Cipla’s subsidiary, InvaGen Pharmaceuticals Inc, has obtained the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA). The EIR follows a recent inspection of InvaGen’s manufacturing facility in New York, USA by the US FDA. The inspection was categorized as ‘Voluntary Action Indicated’ (VAI).

InvaGen had previously received five inspection observations in Form 483 during the inspection, with no repeat observations or data integrity concerns. The inspection covered both routine current Good Manufacturing Practices (GMP) and a Pre-Approval Inspection (PAI) for evaluating a site transfer product within InvaGen’s portfolio.

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