FDA Inspection 1171848 — Hanlim Pharm Co. Ltd.
The FDA completed an inspection of Hanlim Pharm Co. Ltd. on May 31, 2022 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 31, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yongin (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1270 | 21 CFR 211.68(b) | input/output verification |