USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unit

Pharma major Cipla Ltd on Wednesday said it has received one inspectional observation in Form 483 from the US health regulator for its manufacturing facility at Kurkumbh in Maharashtra. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.

"On conclusion of the inspection, the company has received one inspectional observation in Form 483," it added.


The company will work closely with the USFDA and is committed to addressing this observation comprehensively within the stipulated time, Cipla said.