FDA Inspection 619927 — Good Samaritan Medical Center IRB
The FDA completed an inspection of Good Samaritan Medical Center IRB on September 11, 2009 in West Palm Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- West Palm Beach, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |