FDA Inspection
Carolina Bone & Tissue Inc.Carolina Bone & Tissue Inc. – FDA Inspection, Aug 1, 2011
Record Details
This FDA Inspection record concerns Carolina Bone & Tissue Inc., with an inspection on August 1, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carolina Bone & Tissue Inc.
- Inspection Date
- August 1, 2011
- Product Type
- Biologics
View Company Profile
ID · e5303e46-0f49-44a4-8a48-06139a3d4bde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737721
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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