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Procaps S A — FDA Facility Profile

FEI 3008338784

Procaps S A is an FDA-registered facility (FEI 3008338784) located in Colombia (COL). Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Colombia (COL)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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))

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)
  • AEK-9331524-8/40002/1 (Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7624250-0/70002/1 (Mon Sep 29 2025 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)
  • 799-9224105-0/12/4 (Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8424709-5/11/1 (Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7705442-9/12/2 (Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6815174-7/21/1 (Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8158655-2/71/1 (Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources