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1198080

AADCO Medical Inc. — FEI 3001237319

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Randolph, VT (United States)

Facility

Other inspections at this facility

  • 894325 (NAI Wed Aug 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 789227 (NAI Tue Jun 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583581 (NAI Thu Apr 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
310421 CFR 820.30(j)Design history file
316021 CFR 820.184Lack of or inadequate DHR procedures
326621 CFR 820.86Acceptance status
343221 CFR 820.75(b)(2)Documentation of validated process performance