Home / Import refusals / AEK-4511268-4/11/1

FDA Import Refusal AEK-4511268-4/11/1 — Bausch Health US., LLC.

Bausch Health US., LLC. — FEI 3010446985

The FDA refused shipment AEK-4511268-4/11/1 from Bausch Health US., LLC. (United States) on May 18, 2018. The refused product falls under Devices — FLUIDIC, PHACOEMULSIFICATION/PHACOFRAGMENTATION. Cited charges: 118,16,3280,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 18, 2018
Country
United States
Product Category
Devices
Product Code
86MUS FLUIDIC, PHACOEMULSIFICATION/PHACOFRAGMENTATION
Charges
118,16,3280,508

Recent inspections

  • 1238658 (VAI Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1232786 (NAI Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144327 (VAI Wed Jun 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094595 (NAI Thu May 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046331 (NAI Wed Feb 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-4875076-2/11/1 (Mon Apr 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3926284-3/31/1 (Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2642134-6/11/1 (Mon Sep 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5797347-8/11/1 (Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-3870698-2/1/1 (Tue Jan 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources