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572634

Sybaritic, Inc — FEI 2131125

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 30, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Bloomington, MN (United States)

Facility

Other inspections at this facility

  • 1221747 (NAI Thu Oct 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179596 (NAI Thu Sep 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152434 (NAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096300 (NAI Tue Jul 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044931 (OAI Wed Mar 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (116) (Tue Jan 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
330121 CFR 820.100(a)(2)Investigation procedures
418921 CFR 820.198(a)General
419121 CFR 806.10(a)(1)Report of risk to health