FDA Inspection
Blood Assurance Inc.Blood Assurance Inc. – FDA Inspection, Dec 19, 2017
Record Details
This FDA Inspection record concerns Blood Assurance Inc., with an inspection on December 19, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 9cb71365-2c85-438e-84be-e079060b6cbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035323
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blood Assurance Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 17, 2020 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 21, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Blood Assurance Inc.
- FDA Inspection 1259198 - 2024-12-20
- FDA Inspection 1115271 - 2020-01-17
- FDA Inspection 948599 - 2015-11-04
- FDA Inspection 872946 - 2014-03-19
- FDA Inspection 811619 - 2012-12-21
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