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FDA Import Refusal 799-1396140-3/11/1 — MeKo Manufacturing e.K.

MeKo Manufacturing e.K. — FEI 3009937642

The FDA refused shipment 799-1396140-3/11/1 from MeKo Manufacturing e.K. (Germany) on June 4, 2019. The refused product falls under Devices — CATHETER, RETENTION TYPE, BALLOON. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 4, 2019
Country
Germany
Product Category
Devices
Product Code
78EZL CATHETER, RETENTION TYPE, BALLOON
Charges
118,508

Recent inspections

  • 1080539 (VAI Thu Feb 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996283 (NAI Fri Jan 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961490 (OAI Thu Feb 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-2868980-8/11/1 (Thu Mar 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8920617-1/11/1 (Tue May 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6793626-9/11/1 (Wed May 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0769366-5/11/1 (Fri Apr 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-1293140-6/11/1 (Mon Sep 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources