FDA Inspection
SK Biotek Ireland Ltd.SK Biotek Ireland Ltd. – FDA Inspection, May 13, 2022
Record Details
This FDA Inspection record concerns SK Biotek Ireland Ltd., with an inspection on May 13, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SK Biotek Ireland Ltd.
- Inspection Date
- May 13, 2022
- Product Type
- Drugs
View Company Profile
ID · ef5a2a34-3e15-4c6c-99d2-9690fb203a40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228150
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
Other FDA inspections of SK Biotek Ireland Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SK Biotek Ireland Ltd.
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