FDA Inspection 1321728 — Comfortland Medical, Inc.
The FDA completed an inspection of Comfortland Medical, Inc. on June 12, 2026 in Mebane, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mebane, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23025 | ISO 13485:2016 Clause 4.1.5 | Control over outsourced processes not proportionate to risk |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |