Company
SloveniaLek Pharmaceuticals, Ljubljana, Slovenia – FDA Inspections
Inspection records and compliance data for Lek Pharmaceuticals in Ljubljana. 9 FDA inspections on record, 2 Form 483s, last inspected July 26, 2024.
Company Profile
This profile covers Lek Pharmaceuticals based in Ljubljana, Slovenia.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 6
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 1, 2009. Last inspected July 26, 2024.
Most cited issue areas
- Complete test data included in records1 inspection
- Following/documenting laboratory controls1 inspection
- Procedure Deviations Recorded and Justified1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1246916 |
| December 11, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1254088 |
| March 18, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1178973 |
| February 20, 2018 | Not classified | Human Drugs | 1045912 |
| February 24, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1005712 |
| June 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 935159 |
| September 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 848663 |
| April 6, 2012 | VAI | Human Drugs · Drug Quality Assurance | 779021 |
| October 1, 2009 | VAI | Human Drugs · Drug Quality Assurance | 644510 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Lek Pharmaceuticals
FEI Number
3002807460
Address
Verovskova Ulica 57, Ljubljana, Slovenia
Country
Slovenia
ID: 6b651b9c-9e4f-46ac-a02a-ddc22f9bc3a6