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FDA Import Refusal SCS-9125691-8/11/1 — Zydus Lifesciences Limited

Zydus Lifesciences Limited — FEI 3002984011

The FDA refused shipment SCS-9125691-8/11/1 from Zydus Lifesciences Limited (India) on March 11, 2020. The refused product falls under Drugs and Biologics — CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 11, 2020
Country
India
Product Category
Drugs and Biologics
Product Code
64MCY04 CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE)
Charges
75

Recent inspections

  • 1177670 (VAI Fri Aug 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088772 (OAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090231 (NAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047493 (NAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006533 (NAI Thu Feb 16 2017 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-4832752-0/51/1 (Mon Mar 11 2024 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)

FDA data resources