FDA: 14 companies in cities within Travis County received 31 citations in 2025

Martin A. Makary, M.D. Commissioner of Food and Drugs of FDA
Martin A. Makary, M.D. Commissioner of Food and Drugs of FDA
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There were 14 companies in cities associated with Travis County that received FDA citations as a result of 14 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).

This is a 26.3% decrease from the number of companies cited in the previous year.

Of the 31 citations issued, the most common citations were ‘You did not document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of FDA’s official recognition or equivalency determination before importing a food from a foreign supplier and on an annual basis’ and ‘You did not document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the county in which the foreign supplier is located’.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Devices sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).

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.

Companies Located within Travis County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
Armbrust, Inc.Devices09/25/2025Quality Audit/Reaudit – conducted
Armbrust, Inc.Devices09/25/2025Nonconforming product, Lack of or inadequate procedures
Austin’s Natural Frozen Pops, Inc.Food and Cosmetics05/07/2025Develop FSVP
Austin’s Natural Frozen Pops, Inc.Food and Cosmetics05/07/2025Regulatory oversight
Austin’s Natural Frozen Pops, Inc.Food and Cosmetics05/07/2025Good compliance standing
Biofusion Management and Manufacturing, LLCDevices02/26/2025Label to bear a unique device identifier
Biofusion Management and Manufacturing, LLCDevices02/26/2025Management review dates
Biofusion Management and Manufacturing, LLCDevices02/26/2025Quality Audit/Reaudit – conducted
Biofusion Management and Manufacturing, LLCDevices02/26/2025Training records
Biofusion Management and Manufacturing, LLCDevices02/26/2025Calibration, Inspection, etc. Procedures Lack of or Inadequ
Biofusion Management and Manufacturing, LLCDevices02/26/2025Devices subject to device identification GUDID data submission requirements.
Bola Pizza, LLCFood and Cosmetics05/21/2025Personnel
Boomerang’S Foods, Inc.Food and Cosmetics07/24/2025Regulatory oversight
Boomerang’S Foods, Inc.Food and Cosmetics07/24/2025Good compliance standing
Braincheck, Inc.Devices09/18/2025Lack of or inadequate procedures
Flextronics America, LLCDevices10/30/2025Lack of or inadequate process validation
Flextronics America, LLCDevices10/30/2025Lack of or inadequate procedures – Acceptance activities
Flextronics America, LLCDevices10/30/2025Documentation
Happy Health, Inc.Devices05/29/2025Confidentiality, FDA inspection of records
Happy Health, Inc.Devices05/29/2025ClincialTrials.gov statement
Happy Health, Inc.Devices05/29/2025Sponsor’s lack of written monitoring procedures
Happy Health, Inc.Devices05/29/2025Investigator lack of informed consent
Lady Mex Grower, Inc.Food and Cosmetics04/30/2025Develop FSVP
MALK Organics, LLCFood and Cosmetics07/07/2025Regulatory oversight
MALK Organics, LLCFood and Cosmetics07/07/2025Good compliance standing
Mindways Software, Inc.Devices03/05/2025Design changes – Lack of or Inadequate Procedures
Pasco Foods IncorporatedFood and Cosmetics07/25/2025Supplier verification – follow written procedures
Pasco Foods IncorporatedFood and Cosmetics07/25/2025Verification activity before import, periodically
Premier Research Labs, LPFood and Cosmetics03/27/2025Specifications – components
Premier Research Labs, LPFood and Cosmetics03/27/2025Record – person document; time of performance
Texas Children’s Hospital North AustinBiologics09/17/2025Establish, maintain and follow manufacturing SOPs
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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