FDA Inspection
BloodworksBloodworks – FDA Inspection, Mar 27, 2009
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on March 27, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bloodworks
- Inspection Date
- March 27, 2009
- Product Type
- Biologics
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ID · da689a3c-c4f5-4cd9-acc4-d4e782c97dba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572955
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 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 Bloodworks
15| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | Not classified | Seattle District Office | Blood and Blood Products |
| May 3, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 16, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 7, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Bloodworks
- FDA Inspection 1294906 - 2025-12-11
- FDA Inspection 1238690 - 2024-05-03
- FDA Inspection 1146276 - 2021-07-16
- FDA Inspection 1087821 - 2019-04-18
- FDA Inspection 1056331 - 2018-06-07
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