Home / Import refusals / 799-1899088-1/110002/1

FDA Import Refusal 799-1899088-1/110002/1 — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806559

The FDA refused shipment 799-1899088-1/110002/1 from Roche Diagnostics GmbH (Germany) on December 18, 2025. The refused product falls under Devices — INVESTIGATIONAL USE ONLY - IMMUNOLOGY. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 18, 2025
Country
Germany
Product Category
Devices
Product Code
81PCZ INVESTIGATIONAL USE ONLY - IMMUNOLOGY
Charges
118,508

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