FDA Inspection
Sleep Group Solutions, LLCSleep Group Solutions, LLC – FDA Inspection, Feb 23, 2017
Record Details
This FDA Inspection record concerns Sleep Group Solutions, LLC, with an inspection on February 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 79371123-cf29-4b22-b250-21030a9e130e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1005482
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Sleep Group Solutions, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 15, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sleep Group Solutions, LLC
- FDA Inspection 1252970 - 2024-10-22
- FDA Inspection 1181750 - 2022-10-04
- FDA Inspection 879035 - 2014-05-09
- FDA Inspection 640788 - 2010-01-15
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