There were 17 companies in cities associated with Travis County that received FDA citations as a result of 17 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 30.8% increase over the number of companies cited in the previous year.
Of the 45 citations issued, the most common citations were ‘You did not develop an FSVP’ and ‘Minutes of IRB meetings have not been in sufficient detail to show attendance at the meetings, actions taken by the IRB and the vote on actions, including the number of members voting for, against and abstaining’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, 16 should take voluntary actions to correct their managing operations (94.1%). Additionally, one company had to take regulatory and/or administrative actions (5.9%).
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 |
|---|---|---|---|
| AME Austin Seafood Products, Inc. | Food and Cosmetics | 06/28/2024 | Verification procedures – adequacy |
| AME Austin Seafood Products, Inc. | Food and Cosmetics | 06/28/2024 | Signed and dated |
| Dairyland Produce, LLC | Food and Cosmetics | 12/17/2024 | Hazard analysis – Identification of hazard |
| Disruption Labs | Food and Cosmetics | 05/17/2024 | Quality control – supplier qualification |
| Disruption Labs | Food and Cosmetics | 05/17/2024 | Examination, testing; scientifically valid |
| Donald J Garcia Jr., M.D. | Drugs | 10/11/2024 | Case history records- inadequate or inadequate |
| First Day Life, Inc. | Food and Cosmetics | 05/17/2024 | Develop FSVP |
| INBC Trading, LLC. | Food and Cosmetics | 03/21/2024 | Record – translate to English |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Registration |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Recall procedures |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Approved school |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Container testing |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Scheduled process establishment |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Process deviation |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Raw materials, packaging, finished product |
| Jaime’s Foods ATX, LLC | Food and Cosmetics | 05/24/2024 | Maintenance of processing and production records |
| Minamoto Wholesale, Ltd. | Food and Cosmetics | 06/26/2024 | HACCP plan implementation |
| Minamoto Wholesale, Ltd. | Food and Cosmetics | 06/26/2024 | Critical control points |
| Minamoto Wholesale, Ltd. | Food and Cosmetics | 06/26/2024 | Monitoring – adequacy |
| Minamoto Wholesale, Ltd. | Food and Cosmetics | 06/26/2024 | Corrective action plan |
| Minamoto Wholesale, Ltd. | Food and Cosmetics | 06/26/2024 | Ongoing verification – complaints, calibration records |
| NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC | Devices | 07/03/2024 | Lack of or inadequate complaint procedures |
| NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION, LLC | Devices | 07/03/2024 | Evaluation, timeliness, identification |
| PQPR Holdings Limited, LLC | Food and Cosmetics | 06/18/2024 | Personnel – records – training |
| PQPR Holdings Limited, LLC | Food and Cosmetics | 06/18/2024 | Written procedures – pest control |
| PQPR Holdings Limited, LLC | Food and Cosmetics | 06/18/2024 | Records – available; FDA |
| Paul K. Pickrell, M.D. | Biologics | 06/13/2024 | FD-1572, protocol compliance |
| Posy Pharmachem Private Limited | Food and Cosmetics | 05/20/2024 | Develop FSVP |
| RCRC Independent Review Board | Biologics | 06/07/2024 | Minutes of IRB meetings |
| RCRC Independent Review Board | Devices | 06/07/2024 | Minutes of IRB meetings |
| RCRC Independent Review Board | Drugs | 06/07/2024 | Minutes of IRB meetings |
| Shantaba, LLC | Food and Cosmetics | 03/20/2024 | Develop FSVP |
| Shantaba, LLC | Food and Cosmetics | 03/20/2024 | Hazard analysis biological, chemical, physical |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Hazard analysis written |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Evaluation – performance, risk |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Approved supplier procedures – importer established |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Supplier verification – establish written procedures |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Verification activity assurance |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Verification activity frequency |
| Special Global, Inc. | Food and Cosmetics | 01/05/2024 | Verification activity before import, periodically |
| TCNATX, Corp. | Food and Cosmetics | 04/25/2024 | Sanitary operations – Plant maintenance |
| TCNATX, Corp. | Food and Cosmetics | 04/25/2024 | Pest control |
| TCNATX, Corp. | Food and Cosmetics | 04/25/2024 | Equipment and utensils – Design and maintenance |
| TCNATX, Corp. | Food and Cosmetics | 04/25/2024 | Food safety plan |
| Tiny Pies Opco, LLC | Food and Cosmetics | 03/15/2024 | Hazard analysis – Identification of hazard |



