FDA Inspection
ASD Sleep, LLC dba American Sleep DentistryASD Sleep, LLC dba American Sleep Dentistry – FDA Inspection, Sep 12, 2012
Record Details
This FDA Inspection record concerns ASD Sleep, LLC dba American Sleep Dentistry, with an inspection on September 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 12, 2012
- Product Type
- Devices
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ID · ebb746ed-2c36-4415-9fe9-ebb738afbbdd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798526
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| May 2, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ASD Sleep, LLC dba American Sleep Dentistry
- FDA Inspection 1179194 - 2022-09-09
- FDA Inspection 1050682 - 2018-05-02
- FDA Inspection 863605 - 2014-01-24
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