FDA Inspection 1096365 — Fmg Co., Ltd.
The FDA completed an inspection of Fmg Co., Ltd. on Jul 12, 2019 in Chuncheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chuncheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |