Dr Reddy’s Laboratories has recently announced that it has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility (CTO-2) in Bollaram, Hyderabad.
The update follows the company’s earlier intimation on November 19, 2024 regarding the USFDA inspection at the facility. According to Dr Reddy’s Laboratories, the inspection has been classified as Voluntary Action Indicated (VAI), meaning that while certain observations were noted, regulatory action is not required.
In its disclosure, the company stated, “The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is ‘closed’ under 21 CFR 20.64(d)(3).”