Warning letter
Luminex Corporation: warning letter of Jun 26, 2020
FDA warning letter 606267 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 606267 |
|---|---|
| Company | Luminex Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 26, 2020 |
| Posted date | Jul 7, 2020 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 806, 806.10, 820 |
| Inspection city | Northbrook |
| Inspection ZIP | 60062 |
| Inspection start date | Feb 10, 2020 |
| 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: