FDA Inspection
American Red Cross Blood ServicesAmerican Red Cross Blood Services – FDA Inspection, Oct 2, 2009
Record Details
This FDA Inspection record concerns American Red Cross Blood Services, with an inspection on October 2, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 2, 2009
- Product Type
- Biologics
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ID · 43a8675a-2f2c-42b5-a2ed-d95b5766a7e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628931
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of American Red Cross Blood Services
9| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 10, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 20, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for American Red Cross Blood Services
- FDA Inspection 1284586 - 2026-01-28
- FDA Inspection 1074162 - 2018-11-01
- FDA Inspection 1009237 - 2017-04-10
- FDA Inspection 978513 - 2016-07-28
- FDA Inspection 941245 - 2015-08-20
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