FDA inspection
Samchundang Pharm Co., Ltd.: FDA inspection ending Oct 25, 2019
FDA inspection 1107697 · Official Action Indicated (OAI) · Hwaseong
Key facts
| Inspection ID | 1107697 |
|---|---|
| Firm | Samchundang Pharm Co., Ltd. |
| FEI number | 3008425092 |
| Address | Hyangnam Pharmaceutical Industries Complex, 71 Jeyakgongdan2-Gil; Hyangnam-Eup |
| City | Hwaseong |
| Country | Korea (the Republic of) |
| Fiscal year | 2020 |
| Inspection end date | Oct 25, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 599255 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data