FDA Inspection 798910 — K J I Industrial Co., Ltd.
The FDA completed an inspection of K J I Industrial Co., Ltd. on August 30, 2012 in Yangsan-si, Gyeongsangnam-do. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yangsan-si, Gyeongsangnam-do (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |