Warning letter
Royal Philips: warning letter of Sep 9, 2025
FDA warning letter 709948 · Center for Devices and Radiological Health
Key facts
| Reference number | 709948 |
|---|---|
| Company | Royal Philips |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Sep 9, 2025 |
| Posted date | Oct 28, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 892.2050, 820, 803, 803.3, 803.12(a), 803.50(a)(2), 806, 803.52, 806.10 |
| Inspection city | Bothell |
| Inspection ZIP | 98021 |
| Inspection start date | Jan 13, 2025 |
| 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: