Austin News

There were four companies in cities associated with Travis County that received FDA citations as a result of four inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
• You did not establish and maintain records documenting temperature controls for foods that require temperature control for safety.
• The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.

Most of the companies cited were involved in the Food and Cosmetics sector.

All of the 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.

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, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Austin's Natural Frozen Pops, Inc.	Food and Cosmetics	10/24/2023	Develop FSVP
Austin's Natural Frozen Pops, Inc.	Food and Cosmetics	10/24/2023	Hazard analysis biological, chemical, physical
Austin's Natural Frozen Pops, Inc.	Food and Cosmetics	10/24/2023	Document review entity's hazard analysis
Austin's Natural Frozen Pops, Inc.	Food and Cosmetics	10/24/2023	Evaluation - performance, risk
Austin's Natural Frozen Pops, Inc.	Food and Cosmetics	10/24/2023	Approved supplier procedures - importer established
Organicare Nature's Science, LLC	Drugs	12/01/2023	Procedures not in writing, fully followed
Organicare Nature's Science, LLC	Drugs	12/01/2023	Written procedures not established/followed
Organicare Nature's Science, LLC	Drugs	12/01/2023	Written records kept in individual logs
Texafrance, Inc.	Food and Cosmetics	12/06/2023	Process control - Foreign objects
Texafrance, Inc.	Food and Cosmetics	12/06/2023	Modified requirement: Temperature control - Records
Westlake IVF, LLC	Biologics	12/11/2023	Responsible person to determine, document
Westlake IVF, LLC	Biologics	12/11/2023	Statement re: certified testing lab
Westlake IVF, LLC	Biologics	12/11/2023	Labeled re: biohazard, risks, test results
Westlake IVF, LLC	Biologics	12/11/2023	Risk factors, clinical evidence
Westlake IVF, LLC	Biologics	12/11/2023	Eligibility not required--warning labels