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1236625

Apneicare LLC dba Patient Safety Inc. — FEI 3007799743

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 12, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Columbus, OH (United States)

Facility

Other inspections at this facility

  • 1178056 (NAI Tue Aug 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019443 (VAI Wed Jul 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924046 (VAI Tue May 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710837 (NAI Fri Feb 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
2279821 CFR 801.50(a)Labeling requirements for stand-alone software
317221 CFR 820.198(c)Investigation of device failures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures