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FDA Import Refusal JJ8-8750842-9/401/2 — Instrumed GmbH

Instrumed GmbH — FEI 3007290840

The FDA refused shipment JJ8-8750842-9/401/2 from Instrumed GmbH (Germany) on April 25, 2025. The refused product falls under Devices — SPECULUM, VAGINAL, METAL. Cited charge: 290 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 25, 2025
Country
Germany
Product Category
Devices
Product Code
85HDF SPECULUM, VAGINAL, METAL
Charges
290

Recent inspections

  • 1074891 (NAI Thu Oct 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935389 (NAI Thu Jan 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851671 (OAI Thu Aug 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • JJ8-8750842-9/401/1 (Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • JJ8-8584073-3/11/1 (Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • JJ8-8585731-5/11/1 (Fri Jan 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-4782438-6/11/27 (Tue Mar 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-5072257-2/4281/1 (Tue Feb 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources