There were two companies in a city associated with Williamson County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2025, according to reports from 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:
- Procedures for design change have not been established.
- The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
- The results and/or dates of management reviews are not documented.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Label to bear a unique device identifier |
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Management review dates |
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Quality Audit/Reaudit – conducted |
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Training records |
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Biofusion Management and Manufacturing, LLC | Devices | 02/26/2025 | Devices subject to device identification GUDID data submission requirements. |
| Mindways Software, Inc. | Devices | 03/05/2025 | Design changes – Lack of or Inadequate Procedures |






