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FDA Import Refusal AEK-0446125-6/10002/2 — Bayer Healthcare Manufacturing Srl

Bayer Healthcare Manufacturing Srl — FEI 3002806461

The FDA refused shipment AEK-0446125-6/10002/2 from Bayer Healthcare Manufacturing Srl (Italy) on May 12, 2026. The refused product falls under Drugs and Biologics — CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 3 other import refusals on record.

Refusal Details

Date
May 12, 2026
Country
Italy
Product Category
Drugs and Biologics
Product Code
61FAA54 CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1270855 (VAI Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1133402 (VAI Fri Apr 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947913 (NAI Fri Oct 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826683 (NAI Fri Mar 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583049 (VAI Fri Apr 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1606240-0/21/1 (Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1525426-8/1/1 (Wed Nov 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1525426-8/22/1 (Wed Nov 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources