FDA Inspection
Lin, Henry MDLin, Henry MD – FDA Inspection, Jul 1, 2009
Record Details
This FDA Inspection record concerns Lin, Henry MD, with an inspection on July 1, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lin, Henry MD
- Inspection Date
- July 1, 2009
- Product Type
- Drugs
View Company Profile
ID · dc99a260-8976-4190-8cd2-b5224bfb7f50
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 596891
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.56(a)Monitoring investigations
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.53(c)(2)Investigator CV or other statement of qualifications
- 21 CFR 312.58(a)FDA access to sponsor records
- 21 CFR 312.55(a)Investigator brochure
- 21 CFR 312.57(a)Records of receipt, shipment, disposition
- 21 CFR 312.53(d)Selecting monitors
- 21 CFR 312.57(c)Record retention requirement
- 21 CFR 312.6(a)Required label statement
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Other FDA inspections of Lin, Henry MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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