FDA Inspection
American Blood Bank Corp.American Blood Bank Corp. – FDA Inspection, Sep 26, 2014
Record Details
This FDA Inspection record concerns American Blood Bank Corp., with an inspection on September 26, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- American Blood Bank Corp.
- Inspection Date
- September 26, 2014
- Product Type
- Biologics
View Company Profile
ID · 2a916c92-a28b-4cd2-b625-3d51a642a5dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894213
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 610.40(e)Further testing
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| August 7, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 19, 2016 | 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 1098924 - 2019-08-07
- FDA Inspection 980945 - 2016-05-19
- FDA Inspection 799803 - 2012-09-19
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