FDA Inspection
KEDPlasma LLCKEDPlasma LLC – FDA Inspection, Dec 5, 2012
Record Details
This FDA Inspection record concerns KEDPlasma LLC, with an inspection on December 5, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KEDPlasma LLC
- Inspection Date
- December 5, 2012
- Product Type
- Biologics
View Company Profile
ID · 16d62f87-df4b-46e3-8e72-0610eb5cee1a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810579
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.120(b)(2)Destruction of obsolete labels
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of KEDPlasma LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 7, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 18, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 14, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for KEDPlasma LLC
- FDA Inspection 1079365 - 2019-02-05
- FDA Inspection 1053676 - 2018-05-07
- FDA Inspection 949234 - 2015-11-10
- FDA Inspection 941128 - 2015-08-18
- FDA Inspection 711005 - 2011-02-14
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