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FDA Import Refusal AEK-8022490-6/1/2 — Leo Pharma Manufacturing Italy SRL

Leo Pharma Manufacturing Italy SRL — FEI 3002808260

The FDA refused shipment AEK-8022490-6/1/2 from Leo Pharma Manufacturing Italy SRL (Italy) on December 23, 2009. The refused product falls under Drugs and Biologics — FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 2 other import refusals on record.

Refusal Details

Date
December 23, 2009
Country
Italy
Product Category
Drugs and Biologics
Product Code
61WCA45 FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1268874 (VAI Thu Nov 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119539 (VAI Thu Jul 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898337 (NAI Thu Sep 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778271 (NAI Wed Mar 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • FP1-0020719-9/301/1 (Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8022490-6/1/1 (Wed Dec 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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