FDA Inspection
BloodworksBloodworks – FDA Inspection, Dec 20, 2017
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on December 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 5ade7908-b619-4c40-8a4c-f54b2008d3ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035495
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 640.21(g)Informed consent
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bloodworks
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 12, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 21, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bloodworks
- FDA Inspection 1310040 - 2026-03-20
- FDA Inspection 1121903 - 2020-03-12
- FDA Inspection 946892 - 2015-10-21
- FDA Inspection 858747 - 2013-12-13
- FDA Inspection 757231 - 2011-12-13
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