FDA Inspection
Lek PharmaceuticalsLek Pharmaceuticals – FDA Inspection, Mar 18, 2022
Record Details
This FDA Inspection record concerns Lek Pharmaceuticals, with an inspection on March 18, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lek Pharmaceuticals
- Inspection Date
- March 18, 2022
- Product Type
- Drugs
View Company Profile
ID · 45b6f40d-76b3-4a3a-ba54-df7addeaffc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1178973
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
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 |
| February 20, 2018 | Not classified | Office of Inspections and Investigations | |
| 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 1045912 - 2018-02-20
- FDA Inspection 1005712 - 2017-02-24
- FDA Inspection 935159 - 2015-06-30
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