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FDA Import Refusal 799-3964452-0/11/1 — Olympus Corporation of the Americas

Olympus Corporation of the Americas — FEI 2429304

The FDA refused shipment 799-3964452-0/11/1 from Olympus Corporation of the Americas (United States) on November 18, 2020. The refused product falls under Devices — CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 18, 2020
Country
United States
Product Category
Devices
Product Code
78FBN CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID
Charges
118,508

Recent inspections

  • 1107356 (NAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920723 (NAI Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835336 (VAI Fri May 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793907 (OAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709142 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-7640887-3/11/1 (Tue May 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2684282-5/11/1 (Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9572030-7/11/1 (Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9572030-7/11/2 (Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0903063-7/11/1 (Wed Sep 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources