FDA Inspection 721585 — Steward St. Elizabeth's Medical Center
The FDA completed an inspection of Steward St. Elizabeth's Medical Center on April 22, 2011 in Brighton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Brighton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |