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Dr Reddy's Labs gets 2 USFDA observations for Duvvada facilities
![Dr Reddys Labs gets 2 USFDA observations for Duvvada facilities Dr Reddys Labs gets 2 USFDA observations for Duvvada facilities](https://medicaldialogues.in/h-upload/2024/03/09/750x450_233940-usfda-inspection-50-2.webp)
Hyderabad: Dr Reddy's Labs has informed in a recent BSE filing, that the United States Food & Drug Administration (USFDA) has concluded a routine GMP inspection with two observations at the Company's formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, Visakhapatnam.
The inspection was conducted from 8th May to 17th May, 2024.
"We have been issued a Form 483 with two 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.
Established in 1984, Dr Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Dr Reddys 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 Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
Read also: Dr Reddy's Labs expects strong product pipeline in North America for FY25
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-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: editorial@medicaldialogues.in. Contact no. 011-43720751