FDA Inspection 618305 — Bayfront Medical Center- IRB
The FDA completed an inspection of Bayfront Medical Center- IRB on Sep 29, 2009 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saint Petersburg, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7652 | 21 CFR 56.113 | Reporting |