FDA Inspection
KB Medical, Inc.KB Medical, Inc. – FDA Inspection, Sep 7, 2012
Record Details
This FDA Inspection record concerns KB Medical, Inc., with an inspection on September 7, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- KB Medical, Inc.
- Inspection Date
- September 7, 2012
- Product Type
- Biologics
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ID · 4cd96f49-f11d-40f5-8ea2-c0ec240f0fa0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797954
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.195(b)Periodic inspection
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(c)Availability of procedures
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of KB Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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