FDA Inspection
Lek PharmaceuticalsLek Pharmaceuticals – FDA Inspection, Apr 6, 2012
Record Details
This FDA Inspection record concerns Lek Pharmaceuticals, with an inspection on April 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lek Pharmaceuticals
- Inspection Date
- April 6, 2012
- Product Type
- Drugs
View Company Profile
ID · 722555c1-703e-47b6-be9e-48df47a35d48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779021
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
Full citation text and observation details available on the Dashboard.
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 20, 2018 | Not classified | Office of Inspections and Investigations | |
| February 24, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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 1045912 - 2018-02-20
- FDA Inspection 1005712 - 2017-02-24
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