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FDA Import Refusal 231-8256709-5/11/1 — Simtra Deutschland GmbH

Simtra Deutschland GmbH — FEI 3002806419

The FDA refused shipment 231-8256709-5/11/1 from Simtra Deutschland GmbH (Germany) on December 1, 2023. The refused product falls under Drugs and Biologics — MONOCLONAL ANTIBODIES, N.E.C.. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 1, 2023
Country
Germany
Product Category
Drugs and Biologics
Product Code
64OIZ99 MONOCLONAL ANTIBODIES, N.E.C.
Charges
75

Recent inspections

  • 1283802 (OAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206312 (NAI Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161093 (VAI Wed Jan 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106642 (NAI Tue Sep 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056958 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • KH5-4149876-3/11/1 (Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • KH5-4149876-3/21/1 (Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0928632-7/11/1 (Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0928632-7/31/1 (Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7007892-4/1/1 (Thu Dec 09 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources