FDA Inspection
Blood Assurance, Inc.Blood Assurance, Inc. – FDA Inspection, Jan 17, 2014
Record Details
This FDA Inspection record concerns Blood Assurance, Inc., with an inspection on January 17, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Blood Assurance, Inc.
- Inspection Date
- January 17, 2014
- Product Type
- Biologics
View Company Profile
ID · a5f6d9bf-e450-4c7f-b68f-8ecd3a970675
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865201
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 640.72(a)(2)Donor exams, tests, lab data, interviews
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(1)Donor criteria
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blood Assurance, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Blood Assurance, Inc.
- FDA Inspection 1059187 - 2018-06-21
- FDA Inspection 952019 - 2015-12-03
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