FDA Inspection
Dentis USADentis USA – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns Dentis USA, with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dentis USA
- Inspection Date
- August 27, 2015
- Product Type
- Devices
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ID · cd3c3b57-47ca-40d5-a4e6-1a9c96bd7f6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939905
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 1271.265(e)Procedures and release criteria
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Other FDA inspections of Dentis USA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Dentis USA
- FDA Inspection 812191 - 2012-12-04
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