FDA Inspection 1017841 — Nots Co., Ltd
The FDA completed an inspection of Nots Co., Ltd on May 23, 2017 in Gangnam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gangnam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |