USFDA issues 7 inspectional observations to Cipla's Pithampur unit
Cipla Ltd said the US health regulator issued Form 483 containing seven inspectional observations to its Pithampur facility after a cGMP inspection. The USFDA conducted the follow-up inspection from August 17–25, 2026. Cipla noted Form 483 is issued when conditions may violate the FD&C Act and related laws, and said it will address the observations within the stipulated time.
Coverage (4)
- Cipla’s Pithampur facility gets seven observations from FDA (pharma.economictimes.indiatimes.com)
- Cipla’s Pithampur facility receives seven USFDA observations following follow (indianpharmapost.com)
- Cipla Receives 7 USFDA Observations In Form 483 At Pithampur Facility (sahi.com)
- USFDA issues 7 inspectional observations to Cipla's Pithampur unit (moneycontrol.com)