FDA Inspection
KB Medical, Inc.KB Medical, Inc. – FDA Inspection, Jan 11, 2010
Record Details
This FDA Inspection record concerns KB Medical, Inc., with an inspection on January 11, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KB Medical, Inc.
- Inspection Date
- January 11, 2010
- Product Type
- Biologics
View Company Profile
ID · 8e57c728-d47c-4aa4-a6f9-af6a7e4a1421
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637768
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of KB Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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