Cipla Pithampur Facility Gets 7 USFDA Observations in Follow-Up cGMP Inspection
Mumbai: Cipla Limited has received seven inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) following a follow-up current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Pithampur, India.
The inspection was conducted by the USFDA from August 17, 2026, to August 25, 2026. At the conclusion of the inspection, the pharmaceutical company received seven observations in Form 483, according to a regulatory disclosure made by Cipla.
Cipla said it will work closely with the USFDA and is committed to addressing all the observations comprehensively within the stipulated timeframe. The company did not provide further details regarding the nature of the seven observations in its disclosure.
The latest inspection was described as a follow-up cGMP inspection and comes in connection with the company’s earlier disclosures on the matter dated February 18, 2023, August 5, 2023, and November 18, 2023.
Cipla stated that it remains committed to working with the USFDA to comprehensively address the inspectional observations within the prescribed timeline.
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