FDA Inspection
Blood Assurance, Inc.Blood Assurance, Inc. – FDA Inspection, Apr 3, 2009
Record Details
This FDA Inspection record concerns Blood Assurance, Inc., with an inspection on April 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Blood Assurance, Inc.
- Inspection Date
- April 3, 2009
- Product Type
- Biologics
View Company Profile
ID · 70de34e2-23fe-48be-bdfd-badf1b9b0495
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595779
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(b)(1)Donor criteria
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blood Assurance, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 10, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 14, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Blood Assurance, Inc.
- FDA Inspection 1248268 - 2024-08-20
- FDA Inspection 1084428 - 2019-02-11
- FDA Inspection 1021853 - 2017-08-10
- FDA Inspection 941658 - 2015-09-10
- FDA Inspection 818790 - 2013-02-14
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