FDA Inspection 904779 — American Red Cross Donor And Client Support Center
The FDA completed an inspection of American Red Cross Donor And Client Support Center on October 31, 2014 in Philadelphia, 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
- October 31, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |
| 98 | 21 CFR 606.100(c) | Thorough investigations |