FDA Inspection 824916 — New York City Department of Health & Mental Hygiene IRB
The FDA completed an inspection of New York City Department of Health & Mental Hygiene IRB on April 1, 2013 in Long Island City, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 1, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Long Island City, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |