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FDA Import Refusal 310-1328296-3/1/1 — Fougera Pharmaceuticals Inc.

Fougera Pharmaceuticals Inc. — FEI 2432435

The FDA refused shipment 310-1328296-3/1/1 from Fougera Pharmaceuticals Inc. (United States) on December 16, 2008. The refused product falls under Devices — LUBRICANT, PATIENT. Cited charges: 118,341,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 16, 2008
Country
United States
Product Category
Devices
Product Code
80KMJ LUBRICANT, PATIENT
Charges
118,341,508

Recent inspections

  • 1226533 (NAI Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177370 (VAI Wed Aug 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099025 (VAI Thu Aug 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053495 (VAI Tue May 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992924 (VAI Thu Nov 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 112-2441278-8/1/14 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2441278-8/1/15 (Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E7E-1026048-2/4/16 (Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BHC-5003124-2/17/1 (Fri Aug 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M76-8813261-3/1/1 (Fri Nov 21 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources