USFDA Pre-License Inspection at Bachupally biologics facility ends with 7 Form 483 observations

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AI summary

Dr Reddys told stock exchanges that the USFDA completed a Pre-License Inspection at its biologics manufacturing facility in Bachupally, Hyderabad from June 16 to June 25, 2026. The inspection ended with a Form 483 carrying seven observations, which the company will address within the stipulated timeline. This follows earlier inspections disclosed on October 12, 2023 and September 13, 2025.

Likely market impact

Form 483 observations are routine and addressable, but repeat inspections at the same facility may raise concerns about potential approval delays.