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Thursday, October 31, 2024

How many companies in cities across Hays County received FDA citations in 2023?

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There were 10 companies in cities associated with Hays County that received FDA citations as a result of 10 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25% increase over the number of companies cited in the previous year.

Of the 33 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, nine should take voluntary actions to correct their managing operations (90%). Additionally, one company had to take regulatory and/or administrative actions (10%).

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.

Companies Located Within Hays County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Austin's Natural Frozen Pops, Inc.Food and Cosmetics10/24/2023Develop FSVP
Austin's Natural Frozen Pops, Inc.Food and Cosmetics10/24/2023Hazard analysis biological, chemical, physical
Austin's Natural Frozen Pops, Inc.Food and Cosmetics10/24/2023Document review entity's hazard analysis
Austin's Natural Frozen Pops, Inc.Food and Cosmetics10/24/2023Evaluation - performance, risk
Austin's Natural Frozen Pops, Inc.Food and Cosmetics10/24/2023Approved supplier procedures - importer established
G Surgical, LLCDevices03/01/2023Lack of or inadequate receiving acceptance procedures
Luminex CorporationDevices01/13/2023Individual Report of Malfunction
Luminex CorporationDevices01/13/2023Process changes - review, evaluation and revalidation
Luminex CorporationDevices01/13/2023Lack of or inadequate procedures
Night Hawk Frozen Foods, Inc.Food and Cosmetics05/23/2023Hazard analysis - Identification of hazard
Night Hawk Frozen Foods, Inc.Food and Cosmetics05/23/2023Allergen preventive controls - Appropriate (Adequate)
Orange Traders, LLCFood and Cosmetics04/11/2023Develop FSVP
Orange Traders, LLCFood and Cosmetics04/11/2023Identification - entry
Organicare Nature's Science, LLCDrugs12/01/2023Procedures not in writing, fully followed
Organicare Nature's Science, LLCDrugs12/01/2023Written procedures not established/followed
Organicare Nature's Science, LLCDrugs12/01/2023Written records kept in individual logs
Shantaba, LLCFood and Cosmetics07/07/2023Develop FSVP
SpineSmith Holdings, LLCDevices08/01/2023Quality Audit/Reaudit - conducted
SpineSmith Holdings, LLCDevices08/01/2023Training records
SpineSmith Holdings, LLCDevices08/01/2023Design validation - software validation not performed
SpineSmith Holdings, LLCDevices08/01/2023Software validation for automated processes
SpineSmith Holdings, LLCDevices08/01/2023Lack of or inadequate procedures
SpineSmith Holdings, LLCDevices08/01/2023Lack of or inadequate DHR procedures
SpineSmith Holdings, LLCDevices08/01/2023Evaluation, timeliness, identification
Tiff's Treats RBDFood and Cosmetics01/20/2023Qualifications of individuals
Tiff's Treats RBDFood and Cosmetics01/20/2023Sanitary operations - Plant maintenance
Tiff's Treats RBDFood and Cosmetics01/20/2023Manufacturing, processing, packing, holding - Controls
Tiff's Treats RBDFood and Cosmetics01/20/2023Process control - Foreign objects
Westlake IVF, LLCBiologics12/11/2023Responsible person to determine, document
Westlake IVF, LLCBiologics12/11/2023Statement re: certified testing lab
Westlake IVF, LLCBiologics12/11/2023Labeled re: biohazard, risks, test results
Westlake IVF, LLCBiologics12/11/2023Risk factors, clinical evidence
Westlake IVF, LLCBiologics12/11/2023Eligibility not required--warning labels

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