USFDA issues warning letter to Cipla Pithampur facility

Published On 2023-11-20 11:00 GMT | Update On 2023-11-22 06:11 GMT

Mumbai: Cipla has announced that the Company has received a warning letter from the United States Food and Drug Administration (USFDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at its Pithampur manufacturing facility between 6th – 17th February, 2023.

This Warning Letter summarizes contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections.

"The Company will respond to the Warning Letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance. We uphold quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards," Cipla stated in a recent BSE filing.

The said facility was issued eight observations by the USFDA for inspection earlier this year.

In August, the USFDA classified the facility as Official Action Indicated (“OAI”).

Read also: USFDA classifies Cipla Pithampur facility as OAI

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai. Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. The Company is also deepening its presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA issues warning letter to Cipla Pithampur facility

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