FDA Inspection
American Red Cross Blood Services Heart of America RegionAmerican Red Cross Blood Services Heart of America Region – FDA Inspection, Oct 17, 2008
Record Details
This FDA Inspection record concerns American Red Cross Blood Services Heart of America Region, with an inspection on October 17, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 17, 2008
- Product Type
- Biologics
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ID · c66eed95-b754-4054-a6c7-b5fdda8dc2d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 545612
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of American Red Cross Blood Services Heart of America Region
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 15, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 17, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 20, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for American Red Cross Blood Services Heart of America Region
- FDA Inspection 1316496 - 2026-05-06
- FDA Inspection 1175750 - 2022-07-26
- FDA Inspection 1057476 - 2018-06-15
- FDA Inspection 967551 - 2016-03-17
- FDA Inspection 860556 - 2013-12-20
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