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736566

Allwell Medical Corporation — FEI 3007138831

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 20, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Raleigh, NC (United States)

Facility

Other inspections at this facility

  • 1289008 (VAI Fri Oct 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095016 (VAI Tue Jul 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890938 (NAI Wed Jul 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
341521 CFR 820.22Quality Audit/Reaudit - conducted
342721 CFR 820.50(a)(2)Supplier oversight
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures