FDA Inspection 1000874 — Dasan C.N Tek Co., Ltd.
The FDA completed an inspection of Dasan C.N Tek Co., Ltd. on January 26, 2017 in Gimpo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gimpo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |