FDA Inspection
Bloodworks NorthwestBloodworks Northwest – FDA Inspection, Aug 30, 2012
Record Details
This FDA Inspection record concerns Bloodworks Northwest, with an inspection on August 30, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Bloodworks Northwest
- Inspection Date
- August 30, 2012
- Product Type
- Biologics
View Company Profile
ID · 5175393e-57ad-4c46-94a9-63d078166f83
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797471
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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 Northwest
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 3, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2017 | Not classified | Seattle District Office | |
| April 2, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 23, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bloodworks Northwest
- FDA Inspection 1237599 - 2024-04-23
- FDA Inspection 1092951 - 2019-04-03
- FDA Inspection 1006803 - 2017-04-05
- FDA Inspection 920774 - 2015-04-02
- FDA Inspection 830314 - 2013-04-23
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.