Dr Reddy's Labs gets 3 USFDA observations for Srikakulam facility

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-24T11:20:18+05:30 | Updated On 24 Aug 2024 11:20 AM IST

dr reddy Gets CDSCO Panel Nod for Marketing Approval of Siponimod Tablets

Hyderabad: Dr Reddy's Labs has informed in a BSE filing that the United States Food & Drug Administration (USFDA) has completed a product-specific Pre-Approval Inspection (PAI) with three observations at the Company's formulations manufacturing facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh.

The inspection was conducted from August 19, 2024 to August 23, 2024.

"We have been issued a form 483 with three observations, which we will address within the stipulated timeline," the Company stated.

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.

Read also: Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection

Medical Dialogues team had earlier reported that the Company had received 4 observations from the USFDA after GMP inspection at its API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.

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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