FDA Inspection
Crystal Dental lab dba Crystal Dental DesignCrystal Dental lab dba Crystal Dental Design – FDA Inspection, Mar 28, 2018
Record Details
This FDA Inspection record concerns Crystal Dental lab dba Crystal Dental Design, with an inspection on March 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d74c547-8579-4cc7-a8d5-d95efe60e06e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1045897
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review dates
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(a)Design control - no procedures
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