FDA Inspection 1171335 — U.S. Investigational Review Board Inc.
The FDA completed an inspection of U.S. Investigational Review Board Inc. on Jun 6, 2022 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7304 | 21 CFR 56.110(b)(1) | No more than minimal risk |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7693 | 21 CFR 56.106(e) | Changes re: review new products or discontinue reviewing |