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FDA Import Refusal EUV-0004636-9/10002/3 — Laboratorio Magnachem International, S.A.

Laboratorio Magnachem International, S.A. — FEI 3003320065

The FDA refused shipment EUV-0004636-9/10002/3 from Laboratorio Magnachem International, S.A. (Dominican Republic) on May 18, 2026. The refused product falls under Drugs and Biologics — GUAIFENESIN (EXPECTORANT). Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 18, 2026
Country
Dominican Republic
Product Category
Drugs and Biologics
Product Code
64HBY02 GUAIFENESIN (EXPECTORANT)
Charges
118,3280

Recent inspections

  • 1224442 (OAI Fri Nov 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015500 (VAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895604 (VAI Tue Sep 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782783 (VAI Fri Apr 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 814-0356502-1/40002/1K (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 814-0356502-1/40002/1C (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EUV-0003288-0/51/12B (Mon Jul 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EUV-0003288-0/51/12C (Mon Jul 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 814-0206593-2/7/1A (Wed Jul 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources