Home / Import refusals / 8DS-0316389-8/11/1

FDA Import Refusal 8DS-0316389-8/11/1 — Purdue Pharma

Purdue Pharma — FEI 3003287869

The FDA refused shipment 8DS-0316389-8/11/1 from Purdue Pharma (Canada) on September 10, 2020. The refused product falls under Drugs and Biologics — PALONOSETRON HYDROCHLORIDE. Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 10, 2020
Country
Canada
Product Category
Drugs and Biologics
Product Code
61TDI36 PALONOSETRON HYDROCHLORIDE
Charges
118

Recent inspections

  • 1087591 (VAI Fri Apr 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025638 (NAI Fri Aug 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938743 (VAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852516 (VAI Fri Sep 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 734736 (VAI Fri Jul 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-2549728-6/20002/1 (Sun Dec 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BGK-9231146-4/10003/1 (Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BGK-9231146-4/30003/1 (Wed Oct 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-0405203-5/11/8 (Tue Oct 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0329757-8/11/7 (Mon Mar 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources