FDA Inspection
KaVo Dental Technologies LLCKaVo Dental Technologies LLC – FDA Inspection, Dec 1, 2016
Record Details
This FDA Inspection record concerns KaVo Dental Technologies LLC, with an inspection on December 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 63b44ad4-ffe6-4fe4-b0d0-af5e6eb5d660
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.200(d)Service reports
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Other FDA inspections of KaVo Dental Technologies LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2017 | Not classified | Atlanta District Office | |
| December 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for KaVo Dental Technologies LLC
- FDA Inspection 1006357 - 2017-03-03
- FDA Inspection 817608 - 2012-12-19
- FDA Inspection 732070 - 2011-06-10
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