FDA Inspection 665186 — Phelps Memorial Hospital Center
The FDA completed an inspection of Phelps Memorial Hospital Center on Jun 10, 2010 in Sleepy Hollow, NY. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 10, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sleepy Hollow, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 51 | 21 CFR 606.40(c) | Provide adequate toilet facilities |