FDA Inspection 759263 — Frederick Memorial Hospital IRB
The FDA completed an inspection of Frederick Memorial Hospital IRB on Dec 20, 2011 in Frederick, MD. 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
- Dec 20, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Frederick, MD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7337 | 21 CFR 56.115(b) | Retention of records |