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FDA Import Refusal FR1-0019071-4/11/1 — Goodman Co., Ltd

Goodman Co., Ltd — FEI 3007835716

The FDA refused shipment FR1-0019071-4/11/1 from Goodman Co., Ltd (Japan) on December 3, 2024. The refused product falls under Devices — CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 3, 2024
Country
Japan
Product Category
Devices
Product Code
74LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE
Charges
508

Recent inspections

  • 1269122 (NAI Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1227869 (VAI Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • FR1-0019245-4/10002/2 (Tue Aug 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • FR1-0019245-4/10002/1 (Tue Aug 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • FR1-0019201-7/31/1 (Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • FR1-0019201-7/11/1 (Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • FR1-0018965-8/21/1 (Thu Mar 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources