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FDA Import Refusal D82-2245271-5/31/1 — Alkem Laboratories Limited

Alkem Laboratories Limited — FEI 3006370524

The FDA refused shipment D82-2245271-5/31/1 from Alkem Laboratories Limited (India) on September 22, 2025. The refused product falls under Drugs and Biologics — ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC). Cited charges: 115,27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 22, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61JCA08 ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
Charges
115,27

Recent inspections

  • 1106347 (NAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080442 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046054 (VAI Tue Mar 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989408 (VAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854604 (VAI Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9186485-8/50003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3800935-6/40003/1 (Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5624433-0/11/4 (Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5822275-1/21/1 (Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3249890-3/21/1 (Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources