Drug factory · FDA FEI 3002807460
Lek d.d.
Verovskova Ulica 57, Ljubljana, Slovenia
Problems found, fixed voluntarily at FDA's last inspection, Nov 18, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 2 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tislelizumab | Tests it | BeOne Medicines USA, Inc. | 72579-121 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 18, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2024 | No problems found | Bioresearch Monitoring | — |
| Dec 11, 2023 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 13, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 1, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 30, 2015 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Apr 6, 2012 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Registered with FDA for: analysis; label; manufacture; pack; particle size reduction; relabel; repack; sterilize.