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FDA Import Refusal 300-1627746-0/51/1 — Sun Pharma Canada Inc.

Sun Pharma Canada Inc. — FEI 3002808384

The FDA refused shipment 300-1627746-0/51/1 from Sun Pharma Canada Inc. (Canada) on May 6, 2024. The refused product falls under Drugs and Biologics — LORATADINE (ANTI-ASTHMATIC). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 6, 2024
Country
Canada
Product Category
Drugs and Biologics
Product Code
61EAL08 LORATADINE (ANTI-ASTHMATIC)
Charges
118

Recent inspections

  • 1312804 (NAI Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1257703 (NAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180887 (VAI Fri Sep 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088553 (VAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984831 (NAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 300-1919605-5/40003/1 (Fri Aug 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-1919605-5/20003/1 (Fri Aug 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8402344-7/12/1 (Thu May 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-1669942-4/21/1 (Mon Jul 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-1666873-4/11/1 (Mon Jul 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources