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Lek d.d. — FDA Facility Profile

FEI 3002807460

Lek d.d. is an FDA-registered facility (FEI 3002807460) located in Slovenia (SVN). Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION; RELABEL; REPACK; STERILIZE. RegDataLab tracks 8 FDA inspections at this facility.

Facility Details

Location
Slovenia (SVN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION; RELABEL; REPACK; STERILIZE
Source
decrs

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))
  • 848663 (VAI Fri Sep 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779021 (VAI Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 644510 (VAI Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 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)
  • BUP-3528521-5/11/1 (Thu Jan 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8723178-1/11/1 (Fri Nov 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • J37-0009050-2/91/1A (Wed May 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • J37-0009050-2/91/1B (Wed May 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9125423-1/11/1 (Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9125423-1/11/2 (Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources