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Import refusals
/ SCS-0763403-8/12/1
SCS-0763403-8/12/1
Dexcom, Inc. — FEI 3004753838
Recent inspections
1250922
(OAI Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1220386
(NAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
1152320
(NAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
1041434
(VAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
965585
(VAI Tue Mar 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (700835)
(Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (418950)
(Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (96247)
(Fri May 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
SCS-0647837-9/12/1
(Tue May 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
799-3232106-1/11/1
(Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
SCS-1161893-5/11/1
(Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
AEK-4311124-2/11/1
(Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
799-9408766-4/11/1
(Thu Nov 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
Refusal Details
Date
June 5, 2025
Country
United States
Product Category
Devices
Product Code
75QBJ INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Charges
118,3280,341,508