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FDA Import Refusal UPS-3549397-3/11/2 — Alkem Laboratories Limited

Alkem Laboratories Limited — FEI 3006370533

The FDA refused shipment UPS-3549397-3/11/2 from Alkem Laboratories Limited (India) on May 31, 2017. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 31, 2017
Country
India
Product Category
Drugs and Biologics
Product Code
56BCE03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

Recent inspections

  • 1233569 (VAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118336 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140381 (VAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089865 (VAI Fri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007598 (VAI Fri Mar 10 2017 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)
  • D82-2245271-5/31/1 (Mon Sep 22 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)

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