FDA Inspection
ASD Sleep, LLC dba American Sleep DentistryASD Sleep, LLC dba American Sleep Dentistry – FDA Inspection, May 2, 2018
Record Details
This FDA Inspection record concerns ASD Sleep, LLC dba American Sleep Dentistry, with an inspection on May 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8622b3e0-c6ba-4766-bafc-5bfcaed18460
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1050682
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(b)Incoming acceptance records, documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ASD Sleep, LLC dba American Sleep Dentistry
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ASD Sleep, LLC dba American Sleep Dentistry
- FDA Inspection 1179194 - 2022-09-09
- FDA Inspection 863605 - 2014-01-24
- FDA Inspection 798526 - 2012-09-12
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