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FDA Import Refusal 799-8723178-1/11/1 — Lek d.d.

Lek d.d. — FEI 3002807460

The FDA refused shipment 799-8723178-1/11/1 from Lek d.d. (Slovenia) on November 16, 2018. 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
November 16, 2018
Country
Slovenia
Product Category
Drugs and Biologics
Product Code
56BCH03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

Recent inspections

  • 1246916 (NAI Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1254088 (NAI Mon Dec 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178973 (VAI Fri Mar 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005712 (VAI Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935159 (VAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0607191-3/70002/1 (Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3564313-8/40002/1 (Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • J37-0011755-2/21/2 (Thu Mar 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3038547-1/51/1 (Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1417300-8/11/1 (Wed May 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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