FDA Inspection 791207 — The American National Red Cross
The FDA completed an inspection of The American National Red Cross on August 6, 2012 in Cleveland, OH. 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
- August 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |