USFDA14 Oct 2026, 08:30 pm
Dr Reddy's USFDA Inspection: 3 Observations Issued
AI Summary
Dr Reddy's Laboratories Ltd announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at its FTO-9 manufacturing facility in Visakhapatnam from October 8-9, 2026. The inspection resulted in the issuance of a Form 483 with three observations. The company stated it will address these observations within the stipulated timeline.
Key Highlights
- USFDA conducted Pre-Approval Inspection at Visakhapatnam facility.
- Inspection resulted in a Form 483 with three observations.
- Dr Reddy's will address observations within the timeline.
- Facility is FTO-9 manufacturing unit.
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