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950174

Innovative Sterilization Technologies LLC — FEI 3010772758

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 4, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Dayton, OH (United States)

Facility

Other inspections at this facility

  • 1246872 (NAI Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1160547 (VAI Thu Jan 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009415 (OAI Wed Apr 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937368 (OAI Thu Aug 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907935 (VAI Mon Dec 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
237121 CFR 820.30(a)Design control - no procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.