FDA Inspection 795554 — American National Red Cross - Johnstown, PA
The FDA completed an inspection of American National Red Cross - Johnstown, PA on August 24, 2012 in Johnstown, PA. 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 24, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnstown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |