USFDA issues 5 inspectional observations to New York facility of Cipla’s arm

21 Sep 2023 Evaluate

United States Food and Drug Administration (USFDA) has concluded inspection at Cipla’s wholly owned subsidiary -- InvaGen Pharmaceuticals’ manufacturing facility located in Central Islip, Long Island, New York, USA. The said inspection conducted from September 11, 2023 to September 19, 2023. The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen.

On conclusion of the inspection, InvaGen has received 5 inspectional observations in Form 483. There are no repeat or data integrity (DI) observations. The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time. 

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.

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