FDA Inspection
Lek PharmaceuticalsLek Pharmaceuticals – FDA Inspection, Jun 30, 2015
Record Details
This FDA Inspection record concerns Lek Pharmaceuticals, with an inspection on June 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lek Pharmaceuticals
- Inspection Date
- June 30, 2015
- Product Type
- Drugs
View Company Profile
ID · 0a8fc7e3-f9f4-434f-878a-68b96987e873
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935159
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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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 | |
| 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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