FDA Inspection
KEDPlasma LLCKEDPlasma LLC – FDA Inspection, Aug 8, 2012
Record Details
This FDA Inspection record concerns KEDPlasma LLC, with an inspection on August 8, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KEDPlasma LLC
- Inspection Date
- August 8, 2012
- Product Type
- Biologics
View Company Profile
ID · e78e46a2-4102-4d31-99ac-475b56ffc5ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794613
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.61Obtaining consent in an appropriate manner
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of KEDPlasma LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2025 | Not classified | Kansas City District Office | |
| June 25, 2024 | Not classified | Kansas City District Office | |
| September 16, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 19, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for KEDPlasma LLC
- FDA Inspection 1283322 - 2025-10-10
- FDA Inspection 1241871 - 2024-06-25
- FDA Inspection 1153598 - 2021-09-16
- FDA Inspection 1032157 - 2017-10-19
- FDA Inspection 955258 - 2016-01-08
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