FDA Inspection 1005482 — Sleep Group Solutions, LLC

Sleep Group Solutions, LLC — FEI 3007075845

The FDA completed an inspection of Sleep Group Solutions, LLC on Feb 23, 2017 in Hollywood, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 23, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Hollywood, FL (United States)

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313221 CFR 820.120Lack of or inadequate procedures for labeling
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ