FDA Inspection
BloodworksBloodworks – FDA Inspection, Nov 17, 2010
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on November 17, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bloodworks
- Inspection Date
- November 17, 2010
- Product Type
- Biologics
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ID · 0770ece0-fd2f-42da-8305-156d7e56d5c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697962
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
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 |
| December 20, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood 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 |
Other documents for Bloodworks
- FDA Inspection 1310040 - 2026-03-20
- FDA Inspection 1121903 - 2020-03-12
- FDA Inspection 1035495 - 2017-12-20
- FDA Inspection 946892 - 2015-10-21
- FDA Inspection 858747 - 2013-12-13
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