Warning letter
Miach Orthopaedics: warning letter of Aug 19, 2025
FDA warning letter 709827 · Center for Devices and Radiological Health
Key facts
| Reference number | 709827 |
|---|---|
| Company | Miach Orthopaedics |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 19, 2025 |
| Posted date | Aug 26, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 820, 803.50(a), 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.18(b)(1)(i), 803.20(c)(1) and 1 more |
| Inspection city | Westborough |
| Inspection ZIP | 01581 |
| Inspection start date | Mar 31, 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: