Warning letter
Masimo Corporation: warning letter of Aug 12, 2014
FDA warning letter 420381 · Los Angeles District Office
Key facts
| Reference number | 420381 |
|---|---|
| Company | Masimo Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 12, 2014 |
| Posted date | Aug 25, 2014 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803, 820, 803.3 |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Aug 13, 2013 |
| Letter on fda.gov | web.archive.org |
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: