fda_483 · inspection_citation · high
Dr. Reddy's Laboratories Limited -- FDA 483: 5 observations (2025-07-18)
- Event date
- 2025-07-18 00:00:00Z
- Observed
- 2026-07-12 22:32:01Z
- Source ID
- 3012414462-2025-07-18-188140
- Payload hash
- e8626a3f5de9f65135f7d976…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not written. Specifically, Your SOP entitled, "Procedure fo r cleanin~ CbH 4 fa...
Entities
Informational only. Not legal, financial, or medical advice.