Home / Import refusals / AEK-9086317-3/31/1

FDA Import Refusal AEK-9086317-3/31/1 — Ajanta Pharma Limited

Ajanta Pharma Limited — FEI 3012664809

The FDA refused shipment AEK-9086317-3/31/1 from Ajanta Pharma Limited (India) on May 13, 2021. The refused product falls under Drugs and Biologics — LAMOTRIGINE (ANTI-CONVULSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 13, 2021
Country
India
Product Category
Drugs and Biologics
Product Code
61MCY38 LAMOTRIGINE (ANTI-CONVULSANT)
Charges
75

Recent inspections

  • 1210223 (NAI Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098820 (VAI Sat Jun 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045477 (NAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9281602-2/90003/1 (Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3376233-0/50003/1 (Mon Nov 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 799-3558847-6/51/1 (Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6751450-6/11/1 (Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-4770533-3/31/1A (Mon Dec 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources