FDA Inspection 1261013 — Sinsin Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sinsin Pharmaceutical Co., Ltd. on February 14, 2025 in Sejong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sejong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |