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763293

Sunrise Medical (US) LLC — FEI 2937137

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 19, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: 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))
  • 976332 (VAI Fri May 06 2016 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))
  • 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
342721 CFR 820.50(a)(2)Supplier oversight
419121 CFR 806.10(a)(1)Report of risk to health
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month