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FDA Import Refusal 799-8544339-1/20002/1 — Merck Kommanditgesellschaft auf Aktien

Merck Kommanditgesellschaft auf Aktien — FEI 3002806906

The FDA refused shipment 799-8544339-1/20002/1 from Merck Kommanditgesellschaft auf Aktien (Germany) on November 21, 2025. The refused product falls under Drugs and Biologics — BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 21, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
62OCA18 BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
Charges
75

Recent inspections

  • 1233993 (NAI Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1241023 (VAI Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029948 (NAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867759 (NAI Thu Feb 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 653955 (NAI Wed Feb 10 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-1302780-0/10002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6417145-5/11/1 (Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3173833-1/41/1 (Mon Sep 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1470208-2/21/1 (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1470208-2/11/1 (Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources