FDA Import Refusal 799-7731982-8/11/1 — Roche Diagnostics GmbH

Roche Diagnostics GmbH — FEI 3002806559

The FDA refused shipment 799-7731982-8/11/1 from Roche Diagnostics GmbH (Germany) on October 11, 2018. The refused product falls under Devices — SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED). Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 11, 2018
Country
Germany
Product Category
Devices
Product Code
75JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
Charges
118,508