FDA Inspection 1326554 — Scinopharm Taiwan, Ltd.
The FDA completed an inspection of Scinopharm Taiwan, Ltd. on Jun 23, 2026 in Tainan City. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 23, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tainan City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |