FDA Inspection 596891 — Lin, Henry MD
The FDA completed an inspection of Lin, Henry MD on July 1, 2009 in Albuquerque, NM. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 1, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Albuquerque, NM (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7428 | 21 CFR 312.53(c)(2) | Investigator CV or other statement of qualifications |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7461 | 21 CFR 312.58(a) | FDA access to sponsor records |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7505 | 21 CFR 312.55(a) | Investigator brochure |
| 7555 | 21 CFR 312.53(d) | Selecting monitors |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |
| 7632 | 21 CFR 312.6(a) | Required label statement |