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FDA Import Refusal 605-6080323-5/11/2 — Wockhardt Limited

Wockhardt Limited — FEI 3005289335

The FDA refused shipment 605-6080323-5/11/2 from Wockhardt Limited (India) on October 19, 2022. The refused product falls under Drugs and Biologics — ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 19, 2022
Country
India
Product Category
Drugs and Biologics
Product Code
62OCA28 ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
Charges
27

Recent inspections

  • 932595 (OAI Tue May 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825671 (OAI Fri Mar 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 764952 (VAI Fri Jan 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605781 (VAI Thu Apr 30 2009 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)
  • 605-6080323-5/21/1 (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)
  • SCS-4845164-7/11/7 (Wed May 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6841716-8/11/1 (Wed Feb 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources