FDA Inspection 1108244 — Samsung Biologics Co., Ltd.
The FDA completed an inspection of Samsung Biologics Co., Ltd. on Nov 1, 2019 in Yeonsu District. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yeonsu District (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |