FDA Inspection 1179508 — Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)
The FDA completed an inspection of Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) on August 24, 2022 in Hwaseong. 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
- August 24, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hwaseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |