North Austin News

There were 12 companies in cities associated with Williamson County that received FDA citations as a result of 12 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% increase over the number of companies cited in the previous year.

Of the 40 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 11 should take voluntary actions to correct their managing operations (91.7%). Additionally, one company had to take regulatory and/or administrative actions (8.3%).

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
G Surgical, LLC	Devices	03/01/2023	Lack of or inadequate receiving acceptance procedures
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
Luminex Corporation	Devices	01/13/2023	Individual Report of Malfunction
Luminex Corporation	Devices	01/13/2023	Process changes - review, evaluation and revalidation
Luminex Corporation	Devices	01/13/2023	Lack of or inadequate procedures
Orange Traders, LLC	Food and Cosmetics	04/11/2023	Develop FSVP
Orange Traders, LLC	Food and Cosmetics	04/11/2023	Identification - entry
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
Shantaba, LLC	Food and Cosmetics	07/07/2023	Develop FSVP
SpineSmith Holdings, LLC	Devices	08/01/2023	Quality Audit/Reaudit - conducted
SpineSmith Holdings, LLC	Devices	08/01/2023	Training records
SpineSmith Holdings, LLC	Devices	08/01/2023	Design validation - software validation not performed
SpineSmith Holdings, LLC	Devices	08/01/2023	Software validation for automated processes
SpineSmith Holdings, LLC	Devices	08/01/2023	Lack of or inadequate procedures
SpineSmith Holdings, LLC	Devices	08/01/2023	Lack of or inadequate DHR procedures
SpineSmith Holdings, LLC	Devices	08/01/2023	Evaluation, timeliness, identification
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
Tiff's Treats RBD	Food and Cosmetics	01/20/2023	Qualifications of individuals
Tiff's Treats RBD	Food and Cosmetics	01/20/2023	Sanitary operations - Plant maintenance
Tiff's Treats RBD	Food and Cosmetics	01/20/2023	Manufacturing, processing, packing, holding - Controls
Tiff's Treats RBD	Food and Cosmetics	01/20/2023	Process control - Foreign objects
Vincent A. Restivo	Drugs	05/26/2023	FD-1572, protocol compliance
Vincent A. Restivo	Drugs	05/26/2023	Case history records- inadequate or inadequate
Vincent A. Restivo	Drugs	05/26/2023	Safety Reports - Non-Serious Events
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