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The USFDA completed a pre-license inspection at Dr. Reddy's biologics facility in Bachupally, issuing a Form 483 with seven observations. The company states it will address them within the timeline, following prior inspections disclosed in 2023 and 2025.
Dr. Reddy's Receives US FDA Approval For Rituximab Biosimilar
Dr Reddy's Receives US FDA Form 483 With Seven Observations At Biologics Plant
Dr. Reddy's Biologics Plant Receives US FDA Form 483 With Seven Observations