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1243859

Personal Medical Corp. — FEI 3021815

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Redmond, WA (United States)

Facility

Other inspections at this facility

  • 1096798 (VAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910767 (VAI Thu Jan 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809084 (NAI Mon Dec 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 671950 (NAI Tue Jul 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
237121 CFR 820.30(a)Design control - no procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
320021 CFR 820.40(a)Document locations, Dissemination, etc.