Home / Import refusals / 799-4879832-8/11/1

FDA Import Refusal 799-4879832-8/11/1 — Opella Healthcare International SAS

Opella Healthcare International SAS — FEI 3003492806

The FDA refused shipment 799-4879832-8/11/1 from Opella Healthcare International SAS (France) on December 27, 2024. The refused product falls under Drugs and Biologics — LEFLUNOMIDE (ANALGESIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 27, 2024
Country
France
Product Category
Drugs and Biologics
Product Code
60LCB84 LEFLUNOMIDE (ANALGESIC)
Charges
75

Recent inspections

  • 1268935 (VAI Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123990 (VAI Thu Oct 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015497 (VAI Fri Jun 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946883 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853427 (VAI Thu Sep 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1419456-9/11/1 (Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7803761-2/11/1 (Wed Nov 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3038547-1/61/1 (Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 336-9562043-9/1/1 (Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-3781475-4/1/5 (Wed Aug 27 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources