FDA inspection
Aqualex Co., Ltd.: FDA inspection ending Oct 20, 2023
FDA inspection 1220911 · Official Action Indicated (OAI) · Seongnam
Key facts
| Inspection ID | 1220911 |
|---|---|
| Firm | Aqualex Co., Ltd. |
| FEI number | 3010683345 |
| Address | 27 Dunchon-Daero 457beon-Gil, Jungwon, 203 Rm |
| City | Seongnam |
| Country | Korea (the Republic of) |
| Fiscal year | 2024 |
| Inspection end date | Oct 20, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 672292 |
At a glance
- 1–9 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