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Warning Letter

Case 527408 — FEI 3009424796

Facility

Recent inspections

  • 1230547 (VAI Fri Aug 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146978 (VAI Thu Jul 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100191 (VAI Thu Aug 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066747 (VAI Tue Sep 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011997 (OAI Tue May 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Kelyniam Global, Inc.
Date
October 5, 2017
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
Collinsville, CT (United States)