FDA Inspection
BloodworksBloodworks – FDA Inspection, Dec 6, 2011
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on December 6, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bloodworks
- Inspection Date
- December 6, 2011
- Product Type
- Biologics
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ID · a640f885-c8ce-44f0-a948-cfd82e0e0bef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759123
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Bloodworks
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bloodworks
- FDA Inspection 953575 - 2016-01-05
- FDA Inspection 866377 - 2014-02-19
- FDA Inspection 808110 - 2012-11-14
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