Warning letter
Deymed Diagnostic s.r.o.: warning letter of Nov 7, 2023
FDA warning letter 671076 · "OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality"
Key facts
| Reference number | 671076 |
|---|---|
| Company | Deymed Diagnostic s.r.o. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 7, 2023 |
| Posted date | Jan 9, 2024 |
| Issuing office | "OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality" |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Hronov |
| Inspection start date | Mar 24, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- NAI Linked inspection classification
- No 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: