Home / Import refusals / AEK-7595673-8/40002/1

FDA Import Refusal AEK-7595673-8/40002/1 — Encube Ethicals Pvt. Ltd.

Encube Ethicals Pvt. Ltd. — FEI 3005669319

The FDA refused shipment AEK-7595673-8/40002/1 from Encube Ethicals Pvt. Ltd. (India) on September 18, 2025. The refused product falls under Drugs and Biologics — AZELAIC ACID (ANTI-SEBORRHEIC). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 18, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
62SDY03 AZELAIC ACID (ANTI-SEBORRHEIC)
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)
  • 820-4806366-1/20002/1 (Fri May 01 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)

FDA data resources