North Austin News

There were five companies in cities associated with Williamson County that received FDA citations as a result of five 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 150% increase over the number of companies cited in the previous quarter.

Of the 19 citations issued, the most common citations include:

• You did not document your review and assessment of a hazard analysis conducted by another entity.
• You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
• You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.

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
GSV Cooperative	Food and Cosmetics	12/13/2023	LACF compliance
GSV Cooperative	Food and Cosmetics	12/13/2023	Document review entity's hazard analysis
GSV Cooperative	Food and Cosmetics	12/13/2023	Evaluation - performance, risk
GSV Cooperative	Food and Cosmetics	12/13/2023	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