FDA Inspection
DentUSA LaboratoryDentUSA Laboratory – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns DentUSA Laboratory, with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DentUSA Laboratory
- Inspection Date
- April 22, 2010
- Product Type
- Devices
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ID · b018150a-5ec7-4930-a0f7-35576290fca7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658317
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 803.17Lack of Written MDR Procedures
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