Dr Reddy's Labs New York facility gets 2 USFDA observations
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has issued two observations for the company's API Middleburgh facility in New York.
The GMP inspection was conducted from 12th May, 2025 to 16th May, 2025 (US EST time).
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. 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.
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