FDA Inspection 1052335 — Barox Co., Ltd.
The FDA completed an inspection of Barox Co., Ltd. on May 18, 2018 in Jungwon, Seongnam. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jungwon, Seongnam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |