USFDA completes GMP inspection of Dr Reddy’s Hyderabad API manufacturing facility

The inspection closed with zero observations

The United States Food & Drug Administration (USFDA) has completed a GMP inspection at Dr Reddy’s API manufacturing facility in Bollaram, Hyderabad (CTO-3). The inspection was conducted from June 12, 2023 to June 16, 2023. The inspection closed with zero observations.

Additionally, the inspection conducted by the USFDA at company’s formulations manufacturing facility in Srikakulam (FTO SEZ PU2), 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).


API manufacturingDr Reddy’sGMP inspectionUSFDA
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