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•United States

ASD Sleep, LLC dba American Sleep Dentistry, Cedar City, UT – FDA Inspections

Inspection records and compliance data for ASD Sleep, LLC dba American Sleep Dentistry in Cedar City, Utah. 4 FDA inspections on record, 1 Form 483, last inspected September 09, 2022.

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Company Profile

This profile covers ASD Sleep, LLC dba American Sleep Dentistry based in Cedar City, Utah, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
1
Warning letters
0

First inspected September 12, 2012. Last inspected September 9, 2022.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Incoming acceptance records, documentation1 inspection
  • Lack of Written MDR Procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 9, 2022VAIMedical Devices & Rad Health · Compliance: Devices1179194
May 2, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1050682
January 24, 2014VAIMedical Devices & Rad Health · Compliance: Devices863605
September 12, 2012VAIMedical Devices & Rad Health · Postmarket Assurance: Devices798526
FDA documents

Form 483s (1)

  • Form 483s · September 9, 2022
People (1)
James R. Montero
Person
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Company Information

Name

ASD Sleep, LLC dba American Sleep Dentistry

FEI Number

3008313791

Address

2002 N Main St Ste 1, Cedar City, Utah 84721, United States

Country

United States

ID: c4c8df9a-4dd7-4dad-b88d-65cce6a28f59

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