Home / Inspections / 831497

831497

Ad-Tech Medical Instrument Corporation — FEI 2183456

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 5, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Oak Creek, WI (United States)

Facility

Other inspections at this facility

  • 1168052 (VAI Thu Apr 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095446 (VAI Thu Jun 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024308 (NAI Tue Sep 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884179 (NAI Fri Jun 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808283 (VAI Mon Nov 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471921 CFR 820.30(h)Incorrect translation to production specifications
255721 CFR 820.30(c)Design input - documentation
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
367421 CFR 820.30(d)Design output - documentation
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate