FDA Inspection
VitalantVitalant – FDA Inspection, Oct 27, 2009
Record Details
This FDA Inspection record concerns Vitalant, with an inspection on October 27, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vitalant
- Inspection Date
- October 27, 2009
- Product Type
- Biologics
View Company Profile
ID · 5b449116-374b-4b43-9c38-401c94d0b360
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 622905
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65(e)Following manufacturer"s instructions
- 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 Vitalant
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 27, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2017 | Not classified | Philadelphia District Office | |
| April 21, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 1, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Vitalant
- FDA Inspection 1220823 - 2023-10-12
- FDA Inspection 1106294 - 2019-08-27
- FDA Inspection 1005672 - 2017-03-13
- FDA Inspection 923145 - 2015-04-21
- FDA Inspection 816929 - 2013-02-01
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.