FDA Inspection
Degowin Blood CenterDegowin Blood Center – FDA Inspection, Apr 16, 2009
Record Details
This FDA Inspection record concerns Degowin Blood Center, with an inspection on April 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Degowin Blood Center
- Inspection Date
- April 16, 2009
- Product Type
- Biologics
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ID · 09ca0779-7b05-40fd-9309-b235a92b8123
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 580262
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Degowin Blood Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 6, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 24, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Degowin Blood Center
- FDA Inspection 1259069 - 2024-12-12
- FDA Inspection 1094007 - 2019-06-06
- FDA Inspection 1001567 - 2017-02-15
- FDA Inspection 915232 - 2015-02-13
- FDA Inspection 805206 - 2012-10-24
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