Cipla receives Form 483 observation from USFDA for Maharashtra facility

Cipla Ltd, a leading pharmaceutical company, disclosed on Wednesday that it has been issued one inspectional observation in Form 483 by the US health regulator for its manufacturing facility located in Kurkumbh, Maharashtra.

The Form 483, issued by the US Food and Drug Administration (USFDA), signifies observations made by inspectors at the conclusion of an inspection, indicating potential violations of the Food Drug and Cosmetic (FD&C) Act and related regulations.

According to Cipla's regulatory filing, the inspection at its Kurkumbh facility was a routine assessment of current Good Manufacturing Practices (cGMP) conducted by the USFDA from April 29, 2024, to May 8, 2024.

"At the conclusion of the inspection, the company has received one inspectional observation in Form 483," stated Cipla in its filing.

The company affirmed its commitment to collaborating closely with the USFDA to address the observation comprehensively within the stipulated time frame.

Cipla's dedication to maintaining regulatory compliance and ensuring the highest standards of manufacturing quality underscores its commitment to providing safe and effective pharmaceutical products to consumers globally.

(With PTI inputs)