FDA Inspection 1221171 — FirstCham Co., Ltd.
The FDA completed an inspection of FirstCham Co., Ltd. on October 27, 2023 in Eumseong. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 27, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eumseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |