Home / Import refusals / AEK-9028838-0/80003/1

FDA Import Refusal AEK-9028838-0/80003/1 — Morepen Laboratories Limited

Morepen Laboratories Limited — FEI 3002807612

The FDA refused shipment AEK-9028838-0/80003/1 from Morepen Laboratories Limited (India) on December 5, 2025. The refused product falls under Drugs and Biologics — DAPAGLIFLOZIN (ANTI-DIABETIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 5, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61PDA70 DAPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1319478 (NAI Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056327 (NAI Thu Apr 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937997 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713719 (VAI Thu Oct 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9409404-0/180003/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7582764-0/30002/1 (Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4714808-6/11/2 (Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-3876381-6/31/1 (Thu Oct 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1599861-7/4/1 (Thu Dec 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources