Dr. Reddy’s Laboratories Ltd. announced that the United States Food & Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) inspection at its API Mirfield facility in West Yorkshire, UK.
The inspection, which took place from September 1 to September 5, 2025, concluded with the issuance of a Form 483 containing seven observations. The company confirmed it will address the concerns raised by the USFDA within the stipulated timeline .
Company’s response
In its filing with the National Stock Exchange (NSE), BSE, and New York Stock Exchange (NYSE), the company stated: “We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline.”
About the facility
The Mirfield site is one of Dr. Reddy’s key active pharmaceutical ingredient (API) manufacturing facilities in the UK. Inspections of this nature are part of routine regulatory oversight by the USFDA to ensure compliance with global manufacturing standards.
What’s next
The company has not disclosed the specific nature of the observations but emphasized that it will provide a detailed response to the USFDA and work toward resolving the issues in line with regulatory requirements.
