Home / Import refusals / 110-0641174-2/1/1

FDA Import Refusal 110-0641174-2/1/1 — Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. — FEI 1823260

The FDA refused shipment 110-0641174-2/1/1 from Roche Diagnostics Operations, Inc. (United States) on May 16, 2005. The refused product falls under Devices — SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER. Cited charges: 118,333,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 16, 2005
Country
United States
Product Category
Devices
Product Code
75NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Charges
118,333,508

Recent inspections

  • 1193763 (NAI Wed Dec 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094392 (VAI Thu Jun 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988860 (NAI Fri Oct 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984591 (VAI Mon Aug 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934927 (NAI Tue Jul 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-1221399-4/1/1 (Fri May 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 322-0669900-5/1/1 (Wed Mar 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9856844-9/1/1 (Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9657397-9/1/1 (Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 110-0641251-8/1/1 (Mon May 16 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources