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1155197

Collaborative Care Diagnostics, LLC. — FEI 3002619777

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2021
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Eagan, MN (United States)

Facility

Other inspections at this facility

  • 1302172 (NAI Mon Feb 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966212 (NAI Wed Feb 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754147 (NAI Fri Oct 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 579761 (NAI Tue May 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures