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647570

Lifewatch Services Inc — FEI 1000127138

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Rosemont, IL (United States)

Facility

Other inspections at this facility

  • 1153940 (VAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087054 (VAI Tue Apr 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058074 (NAI Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984317 (NAI Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 901295 (OAI Wed Jun 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
316721 CFR 820.198(a)Complete files maintained
337421 CFR 820.198(d)(3)Determination of relationship of device to event
366521 CFR 820.20(b)(3)Management representative
369221 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
369621 CFR 820.100(b)Documentation
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations
63321 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
73221 CFR 803.50(a)(2)Individual Report of Malfunction