FDA Inspection 1108243 — DAEHWA PHARM CO.,LTD.
The FDA completed an inspection of DAEHWA PHARM CO.,LTD. on November 1, 2019 in Hoengseong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hoengseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |