FDA Inspection
Helena A. Yu, MDHelena A. Yu, MD – FDA Inspection, Oct 13, 2015
Record Details
This FDA Inspection record concerns Helena A. Yu, MD, with an inspection on October 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Helena A. Yu, MD
- Inspection Date
- October 13, 2015
- Product Type
- Drugs
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ID · 3b2b3ce9-2508-4671-b265-0883064ead36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945259
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 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
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Other FDA inspections of Helena A. Yu, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Helena A. Yu, MD
- FDA Inspection 1227567 - 2024-01-16
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