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Warning Letter

Case 540535 — FEI 3000718854

Facility

Recent inspections

  • 1277633 (NAI Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181069 (VAI Thu Oct 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096671 (VAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1020072 (OAI Mon Jul 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843584 (NAI Thu Aug 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Custom Assemblies, Inc.
Date
April 6, 2018
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
Pine Level, NC (United States)