USFDA inspection: Dr Reddy's Labs gets 2 observations for Telangana facility
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has issued two observations at the conclusion of an inspection at the company's API manufacturing facility (CTO-5) in Miryalaguda, Telangana, India.
The GMP inspection was conducted from 19th May, 2025 to 24th May, 2025.
"We have been issued a Form 483 with 2 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. 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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