USFDA8 Oct 2026, 03:57 pm
Dr Reddy's USFDA Inspection Yields 2 Observations
AI Summary
Dr Reddy's Laboratories Ltd announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at its FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh. The inspection took place from October 5, 2026, to October 7, 2026. The company received a Form 483 with two observations. Dr. Reddy's has stated that it will address these observations within the stipulated timeline. This disclosure is made under Regulation 30 of SEBI (LODR) Regulations, 2015.
Key Highlights
- USFDA inspection completed at Pydibhimavaram facility.
- Form 483 issued with two observations.
- Company committed to addressing observations promptly.
- Inspection conducted from October 5-7, 2026.
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