USFDA25 Jun 2026, 10:40 pm
Dr Reddy's USFDA Inspection: 7 Observations Issued
AI Summary
Dr Reddy's Laboratories Ltd announced that the United States Food & Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at its biologics manufacturing facility in Bachupally, Hyderabad. The inspection, conducted from June 16 to June 25, 2026, resulted in the issuance of a Form 483 with seven observations. The company stated it will address these observations within the stipulated timeline. This inspection follows previous ones, with disclosures made on October 12, 2023, and September 13, 2025.
Key Highlights
- USFDA completed inspection at Dr Reddy's Hyderabad biologics facility.
- Inspection yielded a Form 483 with seven observations.
- Company committed to addressing observations within timelines.
- This is a continuation of prior USFDA inspections.
- No immediate impact on operations disclosed.
Price Impact
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