USFDA concludes inspection at Cipla Qidong facility with zero observations

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-02T12:29:25+05:30 | Updated On 21 March 2024 3:05 PM IST

Mumbai: Cipla has announced that the United States Food and Drug Administration (USFDA) has concluded a pre-approval inspection with zero Form 483 observations at the manufacturing facility of Cipla (Jiangsu) Pharmaceutical Co., Ltd. (subsidiary of the Company) located in Qidong, Jiangsu Province, China.

The facility was inspected from 26th February, 2024 to 1st March, 2024.

"we hereby notify that a pre-approval inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility of Cipla (Jiangsu) Pharmaceutical Co., Ltd. (subsidiary of the Company) located in Qidong, Jiangsu Province, China from 26th February, 2024 to 1st March, 2024," the Company stated in a BSE filing.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751