Dr Reddy's Labs gets USFDA EIR for Hyderabad facility
Hyderabad: Dr Reddy's labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility in Bollaram, Hyderabad (CTO 1)."The Agency has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21 CFR 20.64(d)(3),"...
Hyderabad: Dr Reddy's labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility in Bollaram, Hyderabad (CTO 1).
"The Agency has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21 CFR 20.64(d)(3)," the company stated in a BSE filing.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Medical Dialogues team had earlier reported that the USFDA had issued a Form 483 with one observation at the completion of the inspection at the company's Bollaram facility.
Read also: Dr Reddys Labs gets one USFDA observation for Hyderabad 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: USFDA concludes inspection at Dr Reddy's Labs Srikakulam facility with zero observations
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