Company
United StatesOto Med Inc, Lake Havasu City, AZ – FDA Inspections
Inspection records and compliance data for Oto Med Inc in Lake Havasu City, Arizona. 3 FDA inspections on record, 1 Form 483, last inspected August 30, 2024.
Company Profile
This profile covers Oto Med Inc based in Lake Havasu City, Arizona, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 18, 2010. Last inspected August 30, 2024.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Complaints1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1248206 |
| April 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1009934 |
| August 18, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 676486 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Oto Med Inc
FEI Number
2021687
Address
1090 Empire Dr, Lake Havasu City, Arizona 86404, United States
Country
United States
ID: d27c3fd7-fb36-4767-9684-7221a218c61a