Company
United StatesMagnatone Hearing Aid Corp, Casselberry, FL – FDA Inspections
Inspection records and compliance data for Magnatone Hearing Aid Corp in Casselberry, Florida. 4 FDA inspections on record, 2 Form 483s, last inspected July 14, 2025.
Company Profile
This profile covers Magnatone Hearing Aid Corp based in Casselberry, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 27, 2016. Last inspected July 14, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Lack of or inadequate procedures3 inspections
- Lack of System for Determining MDR Events2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1275528 |
| December 10, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1112331 |
| July 14, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1018119 |
| June 27, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 974690 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Magnatone Hearing Aid Corp
FEI Number
1044692
Address
170 N Cypress Way, Casselberry, Florida 32707, United States
Country
United States
ID: 7c2ed214-fe8a-4fe7-a063-d8e4092aa3cd