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1112801

NextPhase Medical Devices LLC — FEI 3003174284

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Mansfield, MA (United States)

Facility

Other inspections at this facility

  • 1205707 (NAI Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173291 (NAI Fri Jun 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1142248 (NAI Fri May 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 828777 (VAI Wed Apr 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746838 (VAI Mon Sep 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
323221 CFR 820.72(a)Equipment suitability & capability
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures