USFDA issues alert on Dr Reddy's Hyderabad unit

Dr Reddy’s Laboratories informed stock exchanges that the US Food and Drug Administration (USFDA) has issued a Form-483 with 11 observations after inspecting its manufacturing unit-3 at Bachupally in Hyderabad. “These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. We will address them comprehensively within the stipulated time,” the company said in a statement. Recently, the USFDA had issued a Form-483 with two observations after inspecting Dr Reddy’s manufacturing unit at Srikakulam SEZ in APnomic zone in AP.

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