FDA Inspection
Vitalant Reference and Transfusion ServiceVitalant Reference and Transfusion Service – FDA Inspection, Jan 10, 2018
Record Details
This FDA Inspection record concerns Vitalant Reference and Transfusion Service, with an inspection on January 10, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 10, 2018
- Product Type
- Biologics
View Company Profile
ID · fe45ec2c-ccb3-4e6a-9804-0a9d56ef450a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037237
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 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 Vitalant Reference and Transfusion Service
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 9, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 4, 2008 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant Reference and Transfusion Service
- FDA Inspection 865604 - 2014-02-11
- FDA Inspection 767067 - 2012-02-09
- FDA Inspection 649374 - 2010-03-03
- FDA Inspection 545391 - 2008-11-04
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.