FDA Inspection 743401 — General Hospital Corporation (The)
The FDA completed an inspection of General Hospital Corporation (The) on August 12, 2011 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |