FDA Inspection 1341840 — Brera Medical Incorporated
The FDA completed an inspection of Brera Medical Incorporated on Oct 20, 2026 in Northborough, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 20, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |