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863605

ASD Sleep, LLC dba American Sleep Dentistry — FEI 3008313791

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
January 24, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cedar City, UT (United States)

Facility

Other inspections at this facility

  • 1179194 (NAI Fri Sep 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050682 (NAI Wed May 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798526 (VAI Wed Sep 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file
337521 CFR 820.198(e)Records of complaint investigation
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate