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FDA Import Refusal 336-6853592-0/11/1 — Fenwal International, Inc.

Fenwal International, Inc. — FEI 3002806457

The FDA refused shipment 336-6853592-0/11/1 from Fenwal International, Inc. (Dominican Republic) on November 6, 2017. The refused product falls under Devices — BONE MARROW COLLECTION/TRANSFUSION KIT. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 6, 2017
Country
Dominican Republic
Product Category
Devices
Product Code
80LWE BONE MARROW COLLECTION/TRANSFUSION KIT
Charges
508

Recent inspections

  • 1203534 (VAI Tue Apr 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116846 (NAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987674 (NAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 336-6857269-1/21/1 (Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 336-6856914-3/11/1 (Mon Dec 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 336-6856914-3/21/1 (Mon Dec 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 336-6854147-2/11/1 (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 336-6854148-0/11/1 (Thu Dec 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources