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1203778

Toby Orthopaedics, Inc. — FEI 3008747271

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 28, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
West Miami, FL (United States)

Facility

Other inspections at this facility

  • 1275617 (NAI Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102596 (VAI Wed Sep 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836784 (VAI Wed Jun 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
337521 CFR 820.198(e)Records of complaint investigation
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
407021 CFR 820.30(g)Design validation - documentation