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1202831

Customed, Inc. — FEI 2648727

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 18, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Fajardo, PR (United States)

Facility

Other inspections at this facility

  • 1241487 (VAI Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107809 (NAI Mon Sep 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068203 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991316 (VAI Wed Aug 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925953 (OAI Wed Apr 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310921 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
337521 CFR 820.198(e)Records of complaint investigation
341521 CFR 820.22Quality Audit/Reaudit - conducted