FDA Inspection 829601 — American National Red Cross National Testing Laboratory
The FDA completed an inspection of American National Red Cross National Testing Laboratory on April 30, 2013 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
- April 30, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 86 | 21 CFR 606.100(b)(7) | Methods for performance of all tests |
| 98 | 21 CFR 606.100(c) | Thorough investigations |