FDA Inspection 772476 — Yale-New Haven Hospital - York Street Campus
The FDA completed an inspection of Yale-New Haven Hospital - York Street Campus on Mar 16, 2012 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 16, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |