FDA inspection
Repligen Corporation: FDA inspection ending Feb 8, 2024
FDA inspection 1230139 · Voluntary Action Indicated (VAI) · Irving, TX
Key facts
| Inspection ID | 1230139 |
|---|---|
| Firm | Repligen Corporation |
| FEI number | 1625657 |
| Address | 3400 Royalty Row |
| City | Irving |
| State | TX |
| ZIP | 75062-4946 |
| Fiscal year | 2024 |
| Inspection end date | Feb 8, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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