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FDA Import Refusal 799-1987877-8/11/1 — Proxy Biomedical Ltd.

Proxy Biomedical Ltd. — FEI 3004859928

The FDA refused shipment 799-1987877-8/11/1 from Proxy Biomedical Ltd. (Ireland) on July 18, 2024. The refused product falls under Devices — MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE. Cited charges: 118,341,508 This firm has 3 other import refusals on record.

Refusal Details

Date
July 18, 2024
Country
Ireland
Product Category
Devices
Product Code
78OTN MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE
Charges
118,341,508

Recent inspections

  • 1277841 (NAI Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194237 (NAI Thu Dec 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975462 (NAI Fri Jun 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945696 (NAI Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 599796 (VAI Thu Jul 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5111791-0/11/1 (Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9035864-2/1/1 (Fri Sep 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-5300038-2/1/1 (Thu Feb 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources