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1178056

Apneicare LLC dba Patient Safety Inc. — FEI 3007799743

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 23, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Columbus, OH (United States)

Facility

Other inspections at this facility

  • 1236625 (VAI Fri Apr 12 2024 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures