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735374

Huestis Machine Corporation — FEI 1219183

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Bristol, RI (United States)

Facility

Other inspections at this facility

  • 1173339 (VAI Thu Jun 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025529 (VAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870746 (VAI Thu Mar 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828941 (OAI Mon May 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
232821 CFR 820.22Quality audits - auditor independence
312721 CFR 820.80(e)Documentation
323121 CFR 820.70(i)Documentation of software validation
369621 CFR 820.100(b)Documentation
44721 CFR 820.40Lack of procedures, or not maintained
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.