FDA Inspection
Kedplasma LLCKedplasma LLC – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Kedplasma LLC, with an inspection on January 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Kedplasma LLC
- Inspection Date
- January 22, 2010
- Product Type
- Biologics
View Company Profile
ID · c3414255-7353-4731-8af0-5451082b80ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639646
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)(1)Donor criteria
- 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
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2026 | Not classified | Florida District Office | |
| October 18, 2024 | Not classified | Florida District Office | |
| November 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 26, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 30, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Kedplasma LLC
- FDA Inspection 1314116 - 2026-02-03
- FDA Inspection 1252402 - 2024-10-18
- FDA Inspection 1073782 - 2018-11-01
- FDA Inspection 987762 - 2016-08-26
- FDA Inspection 864145 - 2014-01-30
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