FDA Inspection 1311460 — Contego Medical, Inc
The FDA completed an inspection of Contego Medical, Inc on May 22, 2026 in Raleigh, NC. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Raleigh, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23106 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs incomplete or inadequate |
| 23117 | ISO 13485:2016 Clause 7.3.6 | Inadequate design and development verification for interfaced device |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |