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755661

Odyssey Medical Technologies, LLC. — FEI 3000205819

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 6, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Bartlett, TN (United States)

Facility

Other inspections at this facility

  • 1201803 (VAI Mon Apr 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072292 (NAI Wed Aug 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907357 (NAI Thu Dec 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 614501 (NAI Wed Sep 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
311721 CFR 820.70(i)Software validation for automated processes
312821 CFR 820.90(a)Nonconforming product control
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
326321 CFR 820.250(b)Sampling plans
53721 CFR 820.70(a)Production processes