FDA Inspection
KEDPLASMA, LLCKEDPLASMA, LLC – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns KEDPLASMA, LLC, with an inspection on March 20, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KEDPLASMA, LLC
- Inspection Date
- March 20, 2009
- Product Type
- Biologics
View Company Profile
ID · 411d8720-e29b-4fe0-8735-70adea87c1ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 573983
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 600.10(b)Personnel capabilities
- 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 KEDPLASMA, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 17, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 18, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 18, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for KEDPLASMA, LLC
- FDA Inspection 1199764 - 2023-03-02
- FDA Inspection 1017303 - 2017-05-17
- FDA Inspection 908003 - 2014-12-18
- FDA Inspection 835671 - 2013-06-13
- FDA Inspection 716334 - 2011-03-18
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.