How many companies in cities across Travis County received FDA citations in 2024?

How many companies in cities across Travis County received FDA citations in 2024?
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA — Official Website
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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.

Companies Located Within Travis County Cities and the Citations They Received in 2024
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


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