FDA Inspection 752096 — The American National Red Cross Diagnostic Manufacturing Division
The FDA completed an inspection of The American National Red Cross Diagnostic Manufacturing Division on Nov 4, 2011 in Gaithersburg, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gaithersburg, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3453 | 21 CFR 601.12(c) | Moderate changes to an approved application |
| 3454 | 21 CFR 601.12(d) | Minor changes to an approved application |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |