FDA inspection
Randox Laboratories Limited: FDA inspection ending Aug 8, 2024
FDA inspection 1249066 · Official Action Indicated (OAI) · Antrim
Key facts
| Inspection ID | 1249066 |
|---|---|
| Firm | Randox Laboratories Limited |
| FEI number | 3014607865 |
| Address | 30 Randalstown Road, County Antrim |
| City | Antrim |
| Country | United Kingdom |
| Fiscal year | 2024 |
| Inspection end date | Aug 8, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 696569 |
At a glance
- None 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