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FDA Import Refusal J37-0009050-2/91/1A — Lek d.d.

Lek d.d. — FEI 3002807460

The FDA refused shipment J37-0009050-2/91/1A from Lek d.d. (Slovenia) on May 24, 2017. The refused product falls under Drugs and Biologics — ACETYLCYSTEINE (MUCOLYTIC). Cited charges: 118,16,3280,472 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 24, 2017
Country
Slovenia
Product Category
Drugs and Biologics
Product Code
65BAA01 ACETYLCYSTEINE (MUCOLYTIC)
Charges
118,16,3280,472

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)

FDA data resources