FDA Inspection 895857 — American Natl. Red Cross-Greater Chesapeake & Potomac Region
The FDA completed an inspection of American Natl. Red Cross-Greater Chesapeake & Potomac Region on October 3, 2014 in Baltimore, 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
- October 3, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |