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1160547

Innovative Sterilization Technologies LLC — FEI 3010772758

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 13, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: 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))
  • 1009415 (OAI Wed Apr 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950174 (NAI Wed Nov 04 2015 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
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate