Warning letter
Physitemp Instruments, LLC: warning letter of Nov 12, 2025
FDA warning letter 717394 · Center for Devices and Radiological Health
Key facts
| Reference number | 717394 |
|---|---|
| Company | Physitemp Instruments, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 12, 2025 |
| Posted date | Mar 31, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.20(a), 807.81(b), 801, 801.3, 801.40(a)(1), 801.40(a)(2), 820.3(b), 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(3) and 9 more |
| Inspection city | Clifton |
| Inspection ZIP | 07013 |
| Inspection start date | Apr 29, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: