1253787
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Namdong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |