FDA Inspection
Somnomed IncSomnomed Inc – FDA Inspection, May 23, 2025
Record Details
This FDA Inspection record concerns Somnomed Inc, with an inspection on May 23, 2025, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 2f50efe5-6a92-4576-b0a2-17dd89c981aa
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1269855
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Somnomed Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 21, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Somnomed Inc
- FDA Inspection 1200588 - 2023-03-16
- FDA Inspection 1082321 - 2019-02-21
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