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FDA Import Refusal AEK-4832752-0/51/1 — Zydus Lifesciences Limited

Zydus Lifesciences Limited — FEI 3005430968

The FDA refused shipment AEK-4832752-0/51/1 from Zydus Lifesciences Limited (India) on March 11, 2024. The refused product falls under Drugs and Biologics — CYCLOPHOSPHAMIDE (ANTI-NEOPLASTIC). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 11, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
62IDY15 CYCLOPHOSPHAMIDE (ANTI-NEOPLASTIC)
Charges
118

Recent inspections

  • 1123492 (NAI Mon Mar 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100892 (NAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007281 (NAI Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927215 (VAI Sat May 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808443 (VAI Fri Nov 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-9338374-2/10002/1 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7060415-4/11/1 (Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1876875-2/11/1 (Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7578252-4/11/1 (Fri Mar 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9125691-8/11/1 (Wed Mar 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources