FDA Inspection 597679 — St Agnes Healthcare Blood Bank
The FDA completed an inspection of St Agnes Healthcare Blood Bank on Jul 17, 2009 in Baltimore, MD. 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
- Jul 17, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 9101 | 21 CFR 600.80(c)(2)(ii) | Reporting Requirement - Periodic adv. exp. report content |