USFDA concludes inspection at Dr Reddy's Labs Srikakulam facility with zero observations
The inspection closed with zero observations and a classification of No Action Indicated.
Hyderabad: Pharma major, Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) and a routine GMP inspection at the company's API manufacturing facility in Srikakulam, Andhra Pradesh, India (CTO-6).
The inspection was conducted from 10th July, 2023 to 19th July, 2023.
"The inspection closed with zero observations and a classification of No Action Indicated (NAI)," the company informed in a BSE filing.
NAI means no objectionable conditions or practices were found during the inspection.
Medical Dialogues team had earlier reported that the Company had received the Establishment Inspection Report (EIR) from the USFDA for the formulations manufacturing facility in Srikakulam (FTO SEZ PU2). The Agency had classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection was "closed" under 21 CFR 20.64(d)(3).
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.
