FDA Inspection 1055917 — CMIC CMO Korea Co., Ltd.
The FDA completed an inspection of CMIC CMO Korea Co., Ltd. on Jun 15, 2018 in Bucheon. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bucheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4576 | 21 CFR 211.192 | No written record of investigation |