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FDA Import Refusal SCS-3331210-4/10002/1 — Fareva Amboise

Fareva Amboise — FEI 3000234005

The FDA refused shipment SCS-3331210-4/10002/1 from Fareva Amboise (France) on September 24, 2025. The refused product falls under Drugs and Biologics — AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II). Cited charges: 118,3280,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 24, 2025
Country
France
Product Category
Drugs and Biologics
Product Code
62OCA14 AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
Charges
118,3280,75

Recent inspections

  • 1282366 (OAI Tue Sep 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100819 (VAI Thu Dec 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055251 (VAI Fri May 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014635 (VAI Tue May 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872367 (VAI Tue Mar 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-3588660-3/11/1 (Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3212939-5/11/1 (Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-5756539-3/11/1 (Wed Jul 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6671359-3/41/1 (Mon Jul 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4378324-7/11/1 (Wed Apr 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources