By: IPP Bureau
Last updated : August 06, 2023 11:15 am
The inspection closed with zero observations and a classification of No Action Indicated
Dr. Reddy's Laboratories receives EIR from USFDA for API facility at Bollaram
Dr. Reddy's Laboratories Limited had earlier announced about the inspection conducted by the United States Food & Drug Administration (USFDA) at its API manufacturing facility in Bollaram, Hyderabad (CTO 1). The Company has received the Establishment Inspection Report (EIR). 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).
Aurobindo Pharma's Unit 7 completes USFDA PAI successfully
The United States Food and Drug Administration (US FDA) completed a Pre-Approval Inspection (PAI) at Aurobindo Pharma Ltd's Unit VII, a Formulation Manufacturing facility situated at Jedcherla Mandal, Mahaboob Nagar District, Telangana, from July 28 to August 4, 2023.
The inspection closed with zero observations and a classification of No Action Indicated (NAI).