Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) today completed a product-specific Pre-Approval Inspection (PAI) and a routine GMP inspection with four observations at the Company' formulations manufacturing facility in Srikakulam (FTO SEZ PU2).
The inspection was conducted from 8th May, 2023 to 12th May, 2023.
"We have been issued a Form 483 with four 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.
Read also: Dr Reddys Labs gets one USFDA observation for Hyderabad facility
Medical Dialogues team had earlier reported that the Company had received the Establishment Inspection Report (EIR) from the USFDA for the formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
Read also: Dr Reddy's Labs receives USFDA EIR for Srikakulam facility
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.
Read also: Dr Reddys Labs concludes acquisition of Mayne Pharma's US generic prescription product portfolio
