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FDA Import Refusal 820-4806366-1/20002/1 — Encube Ethicals Pvt. Ltd.

Encube Ethicals Pvt. Ltd. — FEI 3005669319

The FDA refused shipment 820-4806366-1/20002/1 from Encube Ethicals Pvt. Ltd. (India) on May 1, 2026. The refused product falls under Drugs and Biologics — MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 1, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61WAJ18 MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
Charges
118,75

Recent inspections

  • 1240618 (VAI Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093369 (VAI Tue Jun 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 943652 (NAI Thu Aug 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776989 (NAI Fri Mar 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 791-5968439-3/20002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 791-5968439-3/10002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-0550940-0/30002/2 (Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7840099-9/80003/1 (Mon Dec 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7595673-8/60002/1 (Thu Sep 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources