FDA Inspection 1058289 — Caregen Co., Ltd.
The FDA completed an inspection of Caregen Co., Ltd. on Jun 29, 2018 in Gunpo. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gunpo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |