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FDA Import Refusal 101-4507276-5/5/1 — Omron (Dalian) Co., Ltd. (Plant 1)

Omron (Dalian) Co., Ltd. (Plant 1) — FEI 3001373226

The FDA refused shipment 101-4507276-5/5/1 from Omron (Dalian) Co., Ltd. (Plant 1) (China) on September 8, 2015. The refused product falls under Devices — SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. Cited charge: 3260 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 8, 2015
Country
China
Product Category
Devices
Product Code
74DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Charges
3260

Recent inspections

  • 1005604 (NAI Thu Feb 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752079 (OAI Thu Oct 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 562050 (NAI Wed Jan 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 101-4507276-5/8/1 (Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-4507276-5/3/1 (Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-4507276-5/4/1 (Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-4507276-5/6/1 (Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-4507276-5/7/1 (Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources