Home / Import refusals / 462-0121215-9/1/5

FDA Import Refusal 462-0121215-9/1/5 — MedAire, Inc.

MedAire, Inc. — FEI 3005798963

The FDA refused shipment 462-0121215-9/1/5 from MedAire, Inc. (United States) on June 24, 2008. The refused product falls under Devices — HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE). Cited charges: 341,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 24, 2008
Country
United States
Product Category
Devices
Product Code
73KFZ HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
Charges
341,508

Recent inspections

  • 1187470 (NAI Thu Oct 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026160 (NAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878246 (VAI Wed May 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645068 (VAI Thu Feb 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-7711117-5/11/1 (Tue Sep 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6023589-8/1/1 (Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 462-0121215-9/1/2 (Wed Jun 25 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 462-0121215-9/1/4 (Wed Jun 25 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 462-0121215-9/1/1 (Tue Jun 24 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources