Warning letter
Mectronic Medicale S.R.L.: warning letter of Jun 27, 2025
FDA warning letter 707997 · Center for Devices and Radiological Health
Key facts
| Reference number | 707997 |
|---|---|
| Company | Mectronic Medicale S.R.L. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 27, 2025 |
| Posted date | Aug 5, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 1002, 1002.10, 1002.13, 1010, 1010.2, 1040.10, 820, 807.81(b), 803, 803.17, 807.81, 807.81(a)(3)(ii) and 5 more |
| Inspection city | Grassobbio |
| Inspection start date | Feb 24, 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: