Home / Import refusals / SCS-9483386-1/11/1

FDA Import Refusal SCS-9483386-1/11/1 — Vyaire Medical, Inc.

Vyaire Medical, Inc. — FEI 2021710

The FDA refused shipment SCS-9483386-1/11/1 from Vyaire Medical, Inc. (United States) on May 21, 2020. The refused product falls under Devices — VENTILATOR, CONTINUOUS (RESPIRATOR). Cited charges: 118,2480,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 21, 2020
Country
United States
Product Category
Devices
Product Code
73CBK VENTILATOR, CONTINUOUS (RESPIRATOR)
Charges
118,2480,3280

Recent inspections

  • 1169164 (NAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015134 (NAI Fri May 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 903196 (NAI Fri Oct 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 741222 (NAI Mon Aug 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-3024741-3/21/1 (Fri Nov 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-1019725-9/1/1 (Mon Jun 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5386735-6/1/1A (Tue Jan 26 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EO2-0270738-8/1/1 (Fri Jul 27 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 050-4504671-0/1/6 (Fri Nov 07 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources