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976332

Sunrise Medical (US) LLC — FEI 2937137

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 6, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fresno, CA (United States)

Facility

Other inspections at this facility

  • 1014294 (VAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922468 (NAI Wed Apr 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 901289 (NAI Fri Oct 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 763293 (VAI Thu Jan 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 661235 (VAI Mon May 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
314921 CFR 820.180Availability
419121 CFR 806.10(a)(1)Report of risk to health
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction