FDA Inspection 883292 — Yale-New Haven Hospital - York Street Campus
The FDA completed an inspection of Yale-New Haven Hospital - York Street Campus on Jun 12, 2014 in New Haven, CT. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 12, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 166 | 21 CFR 606.170(a) | Adverse reaction - Disposition of Reports |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |