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FDA Import Refusal AEK-7040114-2/1/1 — Wockhardt Limited

Wockhardt Limited — FEI 3002808503

The FDA refused shipment AEK-7040114-2/1/1 from Wockhardt Limited (India) on May 19, 2005. The refused product falls under Drugs and Biologics — CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC). Cited charge: 16 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 19, 2005
Country
India
Product Category
Drugs and Biologics
Product Code
61XIS45 CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
Charges
16

Recent inspections

  • 1097975 (NAI Wed Jun 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089444 (NAI Fri Apr 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921885 (OAI Tue Mar 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844314 (OAI Wed Jul 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 703178 (NAI Fri Dec 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-3185386-5/11/2 (Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 605-6080323-5/11/2 (Wed Oct 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 605-6080323-5/11/1 (Wed Oct 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 605-6080323-5/21/1 (Wed Oct 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-4845164-7/11/7 (Wed May 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources