FDA Inspection
KEDPLASMA LLCKEDPLASMA LLC – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns KEDPLASMA LLC, with an inspection on December 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KEDPLASMA LLC
- Inspection Date
- December 1, 2011
- Product Type
- Biologics
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ID · ed561e3f-8c54-482a-9b23-02741f0d9259
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756105
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of KEDPLASMA LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 18, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for KEDPLASMA LLC
- FDA Inspection 1067753 - 2018-09-20
- FDA Inspection 967776 - 2016-03-18
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