FDA inspection
Custom Tube Manufacturing LLC: FDA inspection ending Feb 16, 2023
FDA inspection 1197551 · Voluntary Action Indicated (VAI) · Yangju
Key facts
| Inspection ID | 1197551 |
|---|---|
| Firm | Custom Tube Manufacturing LLC |
| FEI number | 3010966701 |
| Address | 38-4 Hyeonseokro733beon-Gil, Gwangjeok-Myeon |
| City | Yangju |
| Country | Korea (the Republic of) |
| Fiscal year | 2023 |
| Inspection end date | Feb 16, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No 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