FDA Inspection
SK Biotek Ireland Ltd.SK Biotek Ireland Ltd. – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns SK Biotek Ireland Ltd., with an inspection on November 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5d0b6064-f4c0-4fd8-93ca-cbc6e3b23bf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035255
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of SK Biotek Ireland Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2019 | 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 |
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