FDA Inspection 681143 — American National Red Cross - Johnstown, PA
The FDA completed an inspection of American National Red Cross - Johnstown, PA on September 24, 2010 in Johnstown, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Johnstown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10005 | n/a | Procedural requirements |
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |