Dr Reddy's Labs gets 7 USFDA observations for Srikakulam facility
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has concluded an inspection with seven observations at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India.
The inspection was conducted from 10th July to 18th July, 2025.
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 Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil, and Europe.
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