USFDA issues Form 483 with 8 observations to Cipla for Pithampur facility

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USFDA Form 483
USFDA Form 483

Last Updated on October 9, 2024 by The Health Master

Cipla Ltd. announced that the US Food and Drug Administration (USFDA) issued eight (8) observations following a current good manufacturing practices (cGMP) inspection at its Pithampur manufacturing facility.

US Food and Drug Administration (USFDA) conducted a Good Manufacturing Practices (cGMP) inspection at Cipla’s Pithampur manufacturing facility from 6-17 February, 2023. 

The company said that the observations were in Form 483 and that it would address the matter ‘within stipulated time.’

“On conclusion of the inspection, the Company has received 8 inspectional observations in Form 483. The Company will work closely with the USFDA and is committed to address these comprehensively within stipulated time,” said Cipla in its regulatory filing.

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