FDA Inspection
BloodworksBloodworks – FDA Inspection, May 10, 2019
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on May 10, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 7ba6cb88-cf8d-4185-81aa-79ea72a3101b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089146
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 630.30(a)(1)Donor deferral
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Other FDA inspections of Bloodworks
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 17, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bloodworks
- FDA Inspection 1223133 - 2023-11-08
- FDA Inspection 1019353 - 2017-07-17
- FDA Inspection 884146 - 2014-06-23
- FDA Inspection 796827 - 2012-08-20
- FDA Inspection 718978 - 2011-04-05
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