Company
United StatesSomnetics International, Inc., Fridley, MN – FDA Inspections
Inspection records and compliance data for Somnetics International, Inc. in Fridley, Minnesota. 2 FDA inspections on record, last inspected July 28, 2015.
Company Profile
This profile covers Somnetics International, Inc. based in Fridley, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 17, 2012. Last inspected July 28, 2015.
Most cited issue areas
- Procedures for product review,disposition lack of/inadequate1 inspection
- Product rework documentation, DHR {see also 820.184}1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 28, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 937197 |
| July 17, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 791140 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Somnetics International, Inc.
FEI Number
3008770104
Address
103 Osborne Rd Ne, Fridley, Minnesota 55432, United States
Country
United States
ID: 59c3a482-1fc4-4498-a5ae-2de21133e545