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FDA Import Refusal KH5-6102831-8/1/1 — Patheon Inc.

Patheon Inc. — FEI 3000264888

The FDA refused shipment KH5-6102831-8/1/1 from Patheon Inc. (Canada) on May 9, 2016. The refused product falls under Drugs and Biologics — MODAFINIL (ANTI-DEPRESSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 9, 2016
Country
Canada
Product Category
Drugs and Biologics
Product Code
61NDA74 MODAFINIL (ANTI-DEPRESSANT)
Charges
75

Recent inspections

  • 1198323 (VAI Fri Feb 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088856 (VAI Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999714 (NAI Fri Dec 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948787 (VAI Fri Nov 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915483 (VAI Fri Jan 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-8356423-5/11/1 (Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8SJ-0000567-5/21/1 (Thu Jul 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8SJ-0000567-5/11/1 (Thu Jul 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-1583332-0/11/1 (Thu Apr 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 916-3572773-7/11/1 (Mon Apr 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources