FDA Inspection
The American National Red Cross Diagnostic Manufacturing DivisionThe American National Red Cross Diagnostic Manufacturing Division – FDA Inspection, Nov 4, 2011
Record Details
This FDA Inspection record concerns The American National Red Cross Diagnostic Manufacturing Division, with an inspection on November 4, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 4, 2011
- Product Type
- Biologics
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ID · b309f55f-cecf-48df-a72a-d8be5806015e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752096
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 601.12(c)Moderate changes to an approved application
- 21 CFR 601.12(d)Minor changes to an approved application
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of The American National Red Cross Diagnostic Manufacturing Division
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 27, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 15, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 29, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for The American National Red Cross Diagnostic Manufacturing Division
- FDA Inspection 1326648 - 2026-07-10
- FDA Inspection 1231137 - 2024-02-13
- FDA Inspection 1058813 - 2018-04-27
- FDA Inspection 991584 - 2016-06-15
- FDA Inspection 898271 - 2014-08-29
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