FDA Inspection
Lek PharmaceuticalsLek Pharmaceuticals – FDA Inspection, Feb 20, 2018
Record Details
This FDA Inspection record concerns Lek Pharmaceuticals, with an inspection on February 20, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Laura Fontan (Company Rep)
- Michael Shanks (Issuing Officer)
View Company Profile
ID · 1c205713-c9e8-42a5-aac4-7e8e5a858fac
Inspection Facts
- Inspection number
- 1045912
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
Other FDA inspections of Lek Pharmaceuticals
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 11, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| June 30, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lek Pharmaceuticals
- FDA Inspection 1246916 - 2024-07-26
- FDA Inspection 1254088 - 2023-12-11
- FDA Inspection 1178973 - 2022-03-18
- FDA Inspection 1005712 - 2017-02-24
- FDA Inspection 935159 - 2015-06-30
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