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815073

OMT, LLC — FEI 3005663073

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
January 9, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fort Lauderdale, FL (United States)

Facility

Other inspections at this facility

  • 1262755 (VAI Wed Mar 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179087 (NAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992511 (VAI Tue Nov 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 625447 (VAI Tue Oct 27 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures