FDA Inspection 772743 — Luminis Health Anne Arundel Medical Center Blood Bank
The FDA completed an inspection of Luminis Health Anne Arundel Medical Center Blood Bank on March 16, 2012 in Annapolis, MD. 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
- March 16, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Annapolis, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 106 | 21 CFR 606.120(a) | Separation of labeling operations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |