How many companies in cities across Williamson County received FDA citations in Q1?

How many companies in cities across Williamson County received FDA citations in Q1?
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA — Official Website
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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.

Companies located within Williamson County Cities and the citations they received in Q1
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


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