Home / Import refusals / EMO-0483555-0/10002/1

FDA Import Refusal EMO-0483555-0/10002/1 — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806559

The FDA refused shipment EMO-0483555-0/10002/1 from Roche Diagnostics GmbH (Germany) on April 20, 2026. The refused product falls under Devices — INVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY. Cited charge: 223 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 20, 2026
Country
Germany
Product Category
Devices
Product Code
75PDA INVESTIGATIONAL USE ONLY - CLINICAL CHEMISTRY
Charges
223

Recent inspections

  • 1177109 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103444 (VAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057452 (NAI Thu Apr 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993103 (NAI Fri Nov 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973782 (NAI Fri Apr 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

FDA data resources