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FDA Import Refusal 231-1648494-5/11/1 — Apotex Research Private Limited

Apotex Research Private Limited — FEI 3006076314

The FDA refused shipment 231-1648494-5/11/1 from Apotex Research Private Limited (India) on April 18, 2018. The refused product falls under Drugs and Biologics — CELECOXIB (ANALGESIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 18, 2018
Country
India
Product Category
Drugs and Biologics
Product Code
60LCE83 CELECOXIB (ANALGESIC)
Charges
75

Recent inspections

  • 1233067 (VAI Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081769 (NAI Sat Feb 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970670 (VAI Fri May 20 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886801 (OAI Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851564 (VAI Fri Jul 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 231-1648554-6/11/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1648554-6/21/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1648554-6/31/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1650313-2/11/1 (Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1650313-2/21/1 (Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources