FDA Inspection
Piangwarin Phaosawasdi, M.D.Piangwarin Phaosawasdi, M.D. – FDA Inspection, May 18, 2023
Record Details
This FDA Inspection record concerns Piangwarin Phaosawasdi, M.D., with an inspection on May 18, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2ad17ba9-fe1a-4c3c-bddd-4b75facc66b6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1205609
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 312.64(b)Safety Reports - Serious Events
- 21 CFR 50.20Understandable language
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety Reports - Serious Events
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.20Understandable language
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