Dr Reddy's Labs API Mirfield facility gets 7 USFDA observations
Hyderabad: 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.
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 AML
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.
Read also: Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream
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