FDA Inspection 1276532 — fmg Co., Ltd.
The FDA completed an inspection of fmg Co., Ltd. on July 25, 2025 in Chuncheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chuncheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |