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765527

Sunshine USA, LLC — FEI 3009973354

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 25, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Johnson City, TN (United States)

Facility

Other inspections at this facility

  • 1268194 (VAI Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215779 (NAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948861 (NAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837378 (OAI Fri Jun 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733202 (VAI Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures
500521 CFR 1002.11Failure to submit
500721 CFR 1002.13Failure to submit
503421 CFR 1010.2(c)Certification not based on adequate test/testing program
63021 CFR 803.17Lack of Written MDR Procedures