Home / Import refusals / SCS-9639383-4/11/1

FDA Import Refusal SCS-9639383-4/11/1 — Roche Diabetes Care GmbH

Roche Diabetes Care GmbH — FEI 3011806823

The FDA refused shipment SCS-9639383-4/11/1 from Roche Diabetes Care GmbH (Germany) on April 28, 2025. The refused product falls under Devices — SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED). Cited charges: 118,3280,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 28, 2025
Country
Germany
Product Category
Devices
Product Code
75JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
Charges
118,3280,508

Recent inspections

  • 1002594 (VAI Thu Feb 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-3928292-5/10002/1 (Tue Jun 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-2838142-8/11/1 (Sun May 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-2850115-7/11/1C (Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-3199068-6/21/1 (Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1885362-6/21/1A (Thu Feb 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources