Last Updated on January 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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