FDA Inspection
BloodworksBloodworks – FDA Inspection, Jun 13, 2018
Record Details
This FDA Inspection record concerns Bloodworks, with an inspection on June 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · d77192cb-f7bd-47ad-9c40-102a75cc49ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055551
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 640.21(g)Informed consent
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bloodworks
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 22, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 7, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 25, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 14, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Bloodworks
- FDA Inspection 1166986 - 2022-03-09
- FDA Inspection 952772 - 2015-12-22
- FDA Inspection 861394 - 2014-01-07
- FDA Inspection 780190 - 2012-04-25
- FDA Inspection 639043 - 2010-01-14
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.