FDA Inspection 964103 — Sinsin Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sinsin Pharmaceutical Co., Ltd. on March 11, 2016 in Sejong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sejong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4311 | 21 CFR 211.84(c)(4) | Compositing of Sub Samples |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |