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FDA Import Refusal AEK-8835292-4/11/1 — R-Pharm Germany GmbH

R-Pharm Germany GmbH — FEI 3002807165

The FDA refused shipment AEK-8835292-4/11/1 from R-Pharm Germany GmbH (Germany) on March 10, 2021. The refused product falls under Drugs and Biologics — AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 10, 2021
Country
Germany
Product Category
Drugs and Biologics
Product Code
62ODY14 AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
Charges
75

Recent inspections

  • 1268201 (VAI Tue Feb 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111807 (NAI Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904022 (VAI Fri Nov 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673156 (NAI Fri Jun 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7311878-6/12/1 (Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0050029-6/11/1 (Wed Dec 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-2067066-9/11/3 (Mon Oct 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7155443-7/41/1 (Fri May 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5705059-1/11/1 (Mon May 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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