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FDA Import Refusal 176-0137372-7/101/1 — Laboratorios Dr. Collado S.A.

Laboratorios Dr. Collado S.A. — FEI 3000989764

The FDA refused shipment 176-0137372-7/101/1 from Laboratorios Dr. Collado S.A. (Dominican Republic) on January 9, 2018. The refused product falls under Drugs and Biologics — GUAIFENESIN (EXPECTORANT). Cited charges: 118,16,3280,336 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 9, 2018
Country
Dominican Republic
Product Category
Drugs and Biologics
Product Code
64HDL02 GUAIFENESIN (EXPECTORANT)
Charges
118,16,3280,336

Recent inspections

  • 1204028 (VAI Fri Apr 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989332 (VAI Fri Jun 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909160 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-7735519-2/10002/1 (Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 814-0356502-1/40002/1F (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 176-0031743-6/61/1 (Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • ENM-0920192-2/31/2 (Tue Apr 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M85-1803816-0/31/1C (Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources