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FDA Import Refusal 799-9137770-6/11/2 — Intas Pharmaceuticals Ltd.

Intas Pharmaceuticals Ltd. — FEI 3005890633

The FDA refused shipment 799-9137770-6/11/2 from Intas Pharmaceuticals Ltd. (India) on February 5, 2024. The refused product falls under Drugs and Biologics — TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 5, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
61WDJ52 TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1281036 (OAI Tue Sep 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-3824380-4/10002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9375889-2/30003/1 (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1919971-7/50003/1 (Wed Feb 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9186485-8/190003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9094971-3/10003/1 (Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources