Company
United StatesOtotronix, LLC, White Bear Lake, MN – FDA Inspections
Inspection records and compliance data for Ototronix, LLC in White Bear Lake, Minnesota. 2 FDA inspections on record, last inspected September 05, 2025.
Company Profile
This profile covers Ototronix, LLC based in White Bear Lake, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 20, 2017. Last inspected September 5, 2025.
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2025 | Not classified | Medical Devices & Rad Health | 1281634 |
| July 20, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1020239 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ototronix, LLC
FEI Number
3012118649
Address
5000 Township Pkwy, White Bear Lake, Minnesota 55110, United States
Country
United States
ID: 4825940d-799f-43bb-acd4-21d7d4297b2d