1024046
Wooil C & Tech Corp. — FEI 3010176173
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pyeongtaek (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4321 | 21 CFR 211.101(b) | Identification of new containers |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |