FDA Inspection
Keenan Medical Group, Inc.Keenan Medical Group, Inc. – FDA Inspection, Sep 27, 2011
Record Details
This FDA Inspection record concerns Keenan Medical Group, Inc., with an inspection on September 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Keenan Medical Group, Inc.
- Inspection Date
- September 27, 2011
- Product Type
- Biologics
View Company Profile
ID · a649a920-0290-492d-80ba-542c47ea47dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746137
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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