FDA Inspection
American Blood Bank Corp.American Blood Bank Corp. – FDA Inspection, Aug 7, 2019
Record Details
This FDA Inspection record concerns American Blood Bank Corp., with an inspection on August 7, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · c86c9c2c-2762-4652-a4b5-411f23d4ec98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098924
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 630.30(a)(3)Donor medical history
- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 630.30(b)(1)Unsuitable donation - release
- 21 CFR 640.4(f)Arm preparation
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Other FDA inspections of American Blood Bank Corp.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 14, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 19, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 19, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for American Blood Bank Corp.
- FDA Inspection 1264839 - 2025-03-19
- FDA Inspection 1173726 - 2022-06-14
- FDA Inspection 980945 - 2016-05-19
- FDA Inspection 894213 - 2014-09-26
- FDA Inspection 799803 - 2012-09-19
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