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FDA Inspection 1241487 — Customed, Inc.

Customed, Inc. — FEI 2648727

The FDA completed an inspection of Customed, Inc. on October 4, 2024 in Fajardo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 4, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Fajardo, PR (United States)

Facility

Other inspections at this facility

  • 1202831 (VAI Tue Apr 18 2023 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

FDA data resources