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FDA Import Refusal 112-7020319-6/2/1 — Galderma Laboratories, L.P.

Galderma Laboratories, L.P. — FEI 1000118068

The FDA refused shipment 112-7020319-6/2/1 from Galderma Laboratories, L.P. (United States) on September 1, 2009. The refused product falls under Drugs and Biologics — METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 1, 2009
Country
United States
Product Category
Drugs and Biologics
Product Code
62LCA40 METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
Charges
75

Recent inspections

  • 1202724 (NAI Wed Apr 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034695 (NAI Thu Nov 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028792 (VAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 955708 (NAI Mon Jan 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777005 (NAI Fri Apr 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-0882621-3/20002/1 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1498646-2/12/1 (Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-4831692-2/11/1 (Mon Jun 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1493743-5/11/1 (Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-5793345-2/1/1 (Fri Jun 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources