USFDA cites Cipla's Kurkumbh unit with single observation during inspection

Cipla receives one inspectional observation from USFDA during a routine GMP inspection at its Kurkumbh manufacturing facility. The observation pertains to potential violations of Food Drug and Cosmetic (FD&C) Act. Cipla will address the issue and respond to the USFDA within the specified timeframe.

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.

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