FDA Inspection 745759 — Lin, Henry MD
The FDA completed an inspection of Lin, Henry MD on September 8, 2011 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Albuquerque, NM (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7410 | 21 CFR 312.53(a) | Investigator selection |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |