There were two companies in cities associated with Seminole County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
- Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.
- Quality audits have not been performed.
All of the companies cited were involved in the Devices sector.
Both companies cited should take voluntary actions to correct their managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of System for Determining MDR Events |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Management ensuring quality policy is understood |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Quality Audit/Reaudit – conducted |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Change records, content |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Purchasing controls, Lack of or inadequate procedures |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of or inadequate procedures |
| Magnatone Hearing Aid, CORP | Devices | 07/14/2025 | Lack of or inadequate complaint procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Label to bear a unique device identifier |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Lack of Written MDR Procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Management review – Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Quality System Procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Quality audits – Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Training – Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Design control – no procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Design Validation – Risk analysis not performed/inadequate |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Purchasing controls, Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Lack of or inadequate In-process acceptance procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Nonconforming product, Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Lack of or inadequate procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Lack of or inadequate complaint procedures |
| Tactical Medical Systems Thermal Management Group | Devices | 08/08/2025 | Devices subject to device identification GUDID data submission requirements. |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
