FDA Inspection
KEDPLASMA LLCKEDPLASMA LLC – FDA Inspection, Nov 23, 2011
Record Details
This FDA Inspection record concerns KEDPLASMA LLC, with an inspection on November 23, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KEDPLASMA LLC
- Inspection Date
- November 23, 2011
- Product Type
- Biologics
View Company Profile
ID · a1756f91-fd12-4e85-a683-911f67726124
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756111
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 640.72(d)Donor reaction
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of KEDPLASMA LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for KEDPLASMA LLC
- FDA Inspection 1081610 - 2019-02-08
- FDA Inspection 1037441 - 2017-11-30
- FDA Inspection 967775 - 2015-11-20
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