FDA Inspection 739836 — Bayfront Medical Center- IRB
The FDA completed an inspection of Bayfront Medical Center- IRB on Aug 9, 2011 in Saint Petersburg, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saint Petersburg, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |