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FDA Import Refusal 112-8510248-3/8/1 — Zydus Lifesciences Limited

Zydus Lifesciences Limited — FEI 3006595385

The FDA refused shipment 112-8510248-3/8/1 from Zydus Lifesciences Limited (India) on October 25, 2010. The refused product falls under Drugs and Biologics — OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 25, 2010
Country
India
Product Category
Drugs and Biologics
Product Code
62KBC10 OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
Charges
75

Recent inspections

  • 906809 (OAI Sat Dec 06 2014 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