FDA Inspection 1328256 — Miach Orthopaedics
The FDA completed an inspection of Miach Orthopaedics on Jul 24, 2026 in Westborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23037 | ISO 13485:2016 Clause 4.2.3 | Medical device file does not contain specific requirements |
| 23039 | ISO 13485:2016 Clause 4.2.4 | Document Control Procedure Inadequate |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23175 | ISO 13485:2016 Clause 7.5.7 | Sterilization and sterile barrier system validation procedures not documented |