FDA Inspection 1237995 — Celltrion Inc.
The FDA completed an inspection of Celltrion Inc. on May 3, 2024 in Yeonsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Yeonsu (Korea (the Republic of))
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 9093 | 21 CFR 600.80(b) | Review of Adverse Experiences - SOPs |
| 9099 | 21 CFR 600.80(c)(1)(iii) | Reporting Requirements - submission of reports |