FDA Inspection 587327 — Holy Cross of Silver Spring Blood Bank
The FDA completed an inspection of Holy Cross of Silver Spring Blood Bank on May 5, 2009 in Silver Spring, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Silver Spring, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9089 | 21 CFR 600.14(c) | When to report |