FDA Inspection 1062645 — Skylake Co., Ltd.
The FDA completed an inspection of Skylake Co., Ltd. on Jul 17, 2018 in Geochang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Geochang (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |