FDA Inspection
Comfortland Medical, Inc.Comfortland Medical, Inc. – FDA Inspection, Jun 12, 2026
Record Details
This FDA Inspection record concerns Comfortland Medical, Inc., with an inspection on June 12, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
- Company
- Comfortland Medical, Inc.
- Inspection Date
- June 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 12ccf8f6-c15e-4078-a77d-eb9a95a696c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1321728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.1.5Control over outsourced processes not proportionate to risk
- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of Comfortland Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Comfortland Medical, Inc.
- FDA Inspection 987385 - 2016-09-26
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