FDA Inspection 1208749 — Raphas Co., Ltd.
The FDA completed an inspection of Raphas Co., Ltd. on June 23, 2023 in Seobuk. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seobuk (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 |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |