Austin News

There were three companies in a city associated with Hays County that received FDA citations as a result of three 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 50% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• 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.
• The summary of records for HCT/Ps did not contain a statement that the communicable disease testing was performed by a laboratory certified to perform such testing on human specimens under the Clinical Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for Medicare and Medicaid Services.
• HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with the Biohazard legend, a statement warning of communicable disease risks and a statement warning of the reactive test results.

All of the companies cited were involved in either Biologics, Drugs, or Food and Cosmetics sectors.

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
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