FDA Inspection
Samsung Biologics Co., Ltd.Samsung Biologics Co., Ltd. – FDA Inspection, Feb 28, 2023
Record Details
This FDA Inspection record concerns Samsung Biologics Co., Ltd., with an inspection on February 28, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 769da2e8-0f45-4a78-ae4e-7e9cefc4d32f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201856
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of Samsung Biologics Co., Ltd.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2025 | Not classified | Office of Inspections and Investigations | |
| July 30, 2024 | Not classified | Office of Inspections and Investigations | |
| September 1, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2019 | Not classified | Office of Inspections and Investigations |
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