FDA Inspection
Lek PharmaceuticalsLek Pharmaceuticals – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Lek Pharmaceuticals, with an inspection on February 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 86ecc7de-f878-448b-910f-cb7f2cb553f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005712
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)Written procedures not established/followed
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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 | |
| 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 1045912 - 2018-02-20
- FDA Inspection 935159 - 2015-06-30
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