Company
United StatesSomnomed Inc, Plano, TX – FDA Inspections
Inspection records and compliance data for Somnomed Inc in Plano, Texas. 3 FDA inspections on record, 1 Form 483, last inspected May 23, 2025.
Company Profile
This profile covers Somnomed Inc based in Plano, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected February 21, 2019. Last inspected May 23, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Product rework procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 23, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1269855 |
| March 16, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1200588 |
| February 21, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1082321 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Somnomed Inc
FEI Number
3005598536
Address
6513 Windcrest Dr Ste 100, Plano, Texas 75024, United States
Country
United States
ID: d48c0aa9-aba8-441e-b167-567ae67a58a7