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1191631

Rebuilder Medical, Inc. — FEI 3004987960

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 29, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Charles Town, WV (United States)

Facility

Other inspections at this facility

  • 1172533 (NAI Tue Jun 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109897 (NAI Wed Aug 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063183 (VAI Wed Aug 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900259 (NAI Mon Oct 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733744 (NAI Fri Jul 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
315521 CFR 820.181(a)DMR device specifications
317221 CFR 820.198(c)Investigation of device failures
367721 CFR 820.30(g)Design validation - software validation not performed
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
369621 CFR 820.100(b)Documentation
41921 CFR 820.20(b)Lack of or inadequate organizational structure