USFDA completes inspection of Dr Reddy’s with zero observations

The inspection closed with zero observations

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USFDA Inspection
USFDA Inspection

Last Updated on November 11, 2024 by The Health Master

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.

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).

Understanding GMP, cGMP, and WHO-GMP

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