Home / Import refusals / AEK-4311124-2/11/1

FDA Import Refusal AEK-4311124-2/11/1 — Dexcom, Inc.

Dexcom, Inc. — FEI 3004753838

The FDA refused shipment AEK-4311124-2/11/1 from Dexcom, Inc. (United States) on November 28, 2023. The refused product falls under Devices — INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED. Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 28, 2023
Country
United States
Product Category
Devices
Product Code
75QBJ INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Charges
3280,341

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

Other import refusals

  • SCS-0763403-8/12/1 (Thu Jun 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 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)
  • 799-9408766-4/11/1 (Thu Nov 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources