1096827
GK Cosmetic Co., Ltd. — FEI 3005989570
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Namdong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |