FDA Inspection
Smile Dental LabSmile Dental Lab – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns Smile Dental Lab, with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Smile Dental Lab
- Inspection Date
- April 22, 2010
- Product Type
- Devices
View Company Profile
ID · fcd47618-37b2-420f-b685-daa0b0a4a9ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661193
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.100(a)(7)Identifying relevant info for management review
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.186QSR
- 21 CFR 820.72(b)(2)Calibration documentation
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