Home / Inspections / 959469

959469

Battle Creek Equipment Co. — FEI 1833125

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 10, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fremont, IN (United States)

Facility

Other inspections at this facility

  • 1069066 (VAI Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012495 (OAI Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 914951 (OAI Thu Feb 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844937 (VAI Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799639 (VAI Thu Sep 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
312721 CFR 820.80(e)Documentation
312821 CFR 820.90(a)Nonconforming product control
313021 CFR 820.100(a)Lack of or inadequate procedures
323621 CFR 820.72(b)Calibration procedures - content
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
419121 CFR 806.10(a)(1)Report of risk to health