Company
United StatesSomnowell, Inc., Bellevue, TN – FDA Inspections
Inspection records and compliance data for Somnowell, Inc. in Bellevue, Tennessee. 1 FDA inspection on record (1 OAI), last inspected March 10, 2016.
Company Profile
This profile covers Somnowell, Inc. based in Bellevue, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 10, 2016.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2016 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 961419 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Somnowell, Inc.
FEI Number
3011669995
Address
8533 Mccrory Ln, Bellevue, Tennessee 37221, United States
Country
United States
ID: 7f9ba2f6-b4db-4ab6-9d9f-c1314b1ececc