FDA Inspection 1019952 — C&T Dream Co., Ltd.
The FDA completed an inspection of C&T Dream Co., Ltd. on July 21, 2017 in Cheonan. 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
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cheonan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |