FDA Inspection
Dental Arts Laboratories IncDental Arts Laboratories Inc – FDA Inspection, Jul 18, 2018
Record Details
This FDA Inspection record concerns Dental Arts Laboratories Inc, with an inspection on July 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebdf3baa-a880-4fea-9183-3a2c57273253
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1059259
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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