FDA Inspection 1316708 — Domico Med-Device Llc
The FDA completed an inspection of Domico Med-Device Llc on May 12, 2026 in Fenton, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fenton, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23192 | ISO 13485:2016 Clause 7.6 | Monitoring and measurement requirements not determined |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 23265 | 21 CFR 820.35(a) | Records of complaint investigations do not include required information |