Warning letter
Randox Laboratories Limited: warning letter of Dec 6, 2024
FDA warning letter 696569 · Center for Devices and Radiological Health
Key facts
| Reference number | 696569 |
|---|---|
| Company | Randox Laboratories Limited |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 6, 2024 |
| Posted date | Jan 14, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Antrim |
| Inspection start date | Aug 5, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: