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FDA Import Refusal 510-4446001-5/10002/1 — Aizu Olympus Co., Ltd.

Aizu Olympus Co., Ltd. — FEI 3002964398

The FDA refused shipment 510-4446001-5/10002/1 from Aizu Olympus Co., Ltd. (Japan) on October 28, 2025. The refused product falls under Devices — URETEROSCOPE. Cited charge: 2780 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 28, 2025
Country
Japan
Product Category
Devices
Product Code
78FGB URETEROSCOPE
Charges
2780

Recent inspections

  • 1175911 (OAI Fri Jul 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074155 (NAI Thu Oct 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925884 (NAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821085 (NAI Thu Jan 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

FDA data resources