FDA Inspection
Samsung Biologics Co., Ltd.Samsung Biologics Co., Ltd. – FDA Inspection, Nov 1, 2019
Record Details
This FDA Inspection record concerns Samsung Biologics Co., Ltd., with an inspection on November 1, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Samsung Biologics Co., Ltd.
- Inspection Date
- November 1, 2019
- Product Type
- Drugs
View Company Profile
ID · 7097d01b-422a-4c04-aabf-43ae536c0e32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108244
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
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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 |
| February 28, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 10, 2019 | Not classified | Office of Inspections and Investigations |
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