FDA Inspection
The Metz Dental Laboratory Inc.The Metz Dental Laboratory Inc. – FDA Inspection, May 22, 2017
Record Details
This FDA Inspection record concerns The Metz Dental Laboratory Inc., with an inspection on May 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2f5974e5-5a18-4827-b43b-d6925ac7c492
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1013055
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40Procedures not adequately established or maintained
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Other FDA inspections of The Metz Dental Laboratory Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2024 | Not classified | Cincinnati District Office | |
| July 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Metz Dental Laboratory Inc.
- FDA Inspection 1251943 - 2024-10-07
- FDA Inspection 888360 - 2014-07-21
- FDA Inspection 634744 - 2009-12-10
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