Dr Reddy's Labs API Mirfield facility gets 7 USFDA observations
Dr Reddy's Labs API Mirfield facility gets 7 USFDA observations Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-09-06T14:52:28+05:30 | Updated On 6 Sept 2025 2:52 PM ISTHyderabad: Dr Reddy's Labs has announced that the company has received seven observations from the United States Food & Drug Administration (USFDA) for the API Mirfield facility in West Yorkshire, UK.The GMP inspection was conducted from September 1 to September 5, 2025."We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline," 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.Read also: Dr Reddy's Secures CDSCO Panel Approval to Import, Market Olutasidenib for AMLEstablished in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. Read also: Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Creamdr reddys labsdr reddys labs newsUSFDAUSFDA inspectionRuchika SharmaRuchika 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. 011-43720751Dr. Kamal Kant KohliDr 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. 011-43720751Show Full ArticleNext Story