FDA Inspection
Commerce Evolution, Inc. dba Dental EvolutionCommerce Evolution, Inc. dba Dental Evolution – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns Commerce Evolution, Inc. dba Dental Evolution, with an inspection on November 4, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 4, 2016
- Product Type
- Biologics
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ID · ecfe0379-cdb7-4540-b5bc-612944f229b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995345
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 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 1271.260(e)Storage temperatures recorded, maintained
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