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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Armbrust, Inc. | Devices | 09/25/2025 | Quality Audit/Reaudit – conducted |
| Armbrust, Inc. | Devices | 09/25/2025 | Nonconforming product, Lack of or inadequate procedures |
| Austin’s Natural Frozen Pops, Inc. | Food and Cosmetics | 05/07/2025 | Develop FSVP |
| Austin’s Natural Frozen Pops, Inc. | Food and Cosmetics | 05/07/2025 | Regulatory oversight |
| Austin’s Natural Frozen Pops, Inc. | Food and Cosmetics | 05/07/2025 | Good compliance standing |
| 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. |
| Bola Pizza, LLC | Food and Cosmetics | 05/21/2025 | Personnel |
| Boomerang’S Foods, Inc. | Food and Cosmetics | 07/24/2025 | Regulatory oversight |
| Boomerang’S Foods, Inc. | Food and Cosmetics | 07/24/2025 | Good compliance standing |
| Braincheck, Inc. | Devices | 09/18/2025 | Lack of or inadequate procedures |
| Flextronics America, LLC | Devices | 10/30/2025 | Lack of or inadequate process validation |
| Flextronics America, LLC | Devices | 10/30/2025 | Lack of or inadequate procedures – Acceptance activities |
| Flextronics America, LLC | Devices | 10/30/2025 | Documentation |
| Happy Health, Inc. | Devices | 05/29/2025 | Confidentiality, FDA inspection of records |
| Happy Health, Inc. | Devices | 05/29/2025 | ClincialTrials.gov statement |
| Happy Health, Inc. | Devices | 05/29/2025 | Sponsor’s lack of written monitoring procedures |
| Happy Health, Inc. | Devices | 05/29/2025 | Investigator lack of informed consent |
| Lady Mex Grower, Inc. | Food and Cosmetics | 04/30/2025 | Develop FSVP |
| MALK Organics, LLC | Food and Cosmetics | 07/07/2025 | Regulatory oversight |
| MALK Organics, LLC | Food and Cosmetics | 07/07/2025 | Good compliance standing |
| Mindways Software, Inc. | Devices | 03/05/2025 | Design changes – Lack of or Inadequate Procedures |
| Pasco Foods Incorporated | Food and Cosmetics | 07/25/2025 | Supplier verification – follow written procedures |
| Pasco Foods Incorporated | Food and Cosmetics | 07/25/2025 | Verification activity before import, periodically |
| Premier Research Labs, LP | Food and Cosmetics | 03/27/2025 | Specifications – components |
| Premier Research Labs, LP | Food and Cosmetics | 03/27/2025 | Record – person document; time of performance |
| Texas Children’s Hospital North Austin | Biologics | 09/17/2025 | Establish, maintain and follow manufacturing SOPs |







