Home / Import refusals / AEK-7560502-0/10001/1

FDA Import Refusal AEK-7560502-0/10001/1 — Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc — FEI 3008444937

The FDA refused shipment AEK-7560502-0/10001/1 from Zydus Pharmaceuticals (USA) Inc (United States) on October 14, 2025. The refused product falls under Drugs and Biologics — VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 14, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
61NCY80 VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT)
Charges
75

Recent inspections

  • 1122499 (NAI Thu Feb 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878016 (NAI Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710971 (VAI Tue Feb 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 666881 (NAI Mon Jun 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605085 (NAI Tue Aug 11 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-0544677-9/11/3 (Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9659930-0/11/1 (Fri Sep 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1721699-4/11/1 (Wed Jul 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1721699-4/11/8 (Wed Jul 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0627999-4/21/1 (Wed Jun 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources