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FDA Import Refusal AEK-7624250-0/70002/1 — Procaps S.A.

Procaps S.A. — FEI 3008338784

The FDA refused shipment AEK-7624250-0/70002/1 from Procaps S.A. (Colombia) on September 29, 2025. The refused product falls under Drugs and Biologics — DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 29, 2025
Country
Colombia
Product Category
Drugs and Biologics
Product Code
62GCE90 DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
Charges
118,75

Recent inspections

  • 1206744 (NAI Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091042 (NAI Mon Apr 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946057 (NAI Fri Oct 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787825 (VAI Fri Jun 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 561492 (VAI Thu Jan 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-3088563-6/10002/1 (Mon Jul 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2196121-4/10002/1I (Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 799-9051089-6/20003/1 (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9331524-8/40002/1 (Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0937537-2/10002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources