FDA Inspection 879041 — Hanlim Pharm Co. Ltd.
The FDA completed an inspection of Hanlim Pharm Co. Ltd. on Apr 18, 2014 in Yongin. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yongin (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2198 | 21 CFR 211.186(b)(3) | Component Name and Code |