No observations: USFDA inspection at Cipla arm InvaGen New York plant concludes

Mumbai: Drugmaker Cipla has announced that the United States Food and Drug Administration (USFDA) has concluded inspection with zero Form 483 observations at the manufacturing facility unit 1 and 2 of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company located in Hauppauge, Long Island, New York, USA.

The facility was inspected from 16th October 2023 to 25th October 2023.

"We hereby notify that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility unit 1 and 2 of InvaGen Pharmaceuticals Inc. (wholly owned subsidiary of the Company) located in Hauppauge, Long Island, New York, USA from 16th October 2023 to 25th October 2023," the Company stated in a recent BSE filing.

An FDA 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. 

Medical Dialogues team had earlier reported that the New York manufacturing facility of InvaGen Pharmaceuticals Inc. had received the EIR (Establishment Inspection Report) from the US Food and Drug Administration (USFDA) on the classification of the inspection as Voluntary Action Indicated (VAI). Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

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