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Thursday, October 31, 2024

FDA: 18 companies in cities within Comal County received 48 citations in 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

There were 18 companies in cities associated with Comal County that received FDA citations as a result of 18 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous year.

Of the 48 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, 16 should take voluntary actions to correct their managing operations (88.9%). Additionally, one company had to take regulatory and/or administrative actions (5.6%).

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 Comal County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Atlas Medical Holdings, Inc.Biologics09/21/2023All core requirements covered in program
Atlas Medical Holdings, Inc.Biologics09/21/2023Evaluation--microorganisms, damage
Blue Baja, LLCFood and Cosmetics03/03/2023Written procedures - personnel qualifications
Blue Baja, LLCFood and Cosmetics03/03/2023Written procedures - holding
Blue Baja, LLCFood and Cosmetics03/03/2023Written procedures - returned dietary supplement
Blue Baja, LLCFood and Cosmetics03/03/2023Written procedures - product complaint
C. T. Grocers, LLCFood and Cosmetics03/01/2023Hazard analysis written
C. T. Grocers, LLCFood and Cosmetics03/01/2023Verification activity before import, periodically
Dulces La Mejor, LLCFood and Cosmetics04/21/2023Hazard analysis written
Dulces La Mejor, LLCFood and Cosmetics04/21/2023Hazard analysis biological, chemical, physical
ErgoMed, Inc.Devices12/06/2023Label to bear a unique device identifier
ErgoMed, Inc.Devices12/06/2023Complaints
ErgoMed, Inc.Devices12/06/2023Devices subject to device identification GUDID data submission requirements.
Footprint Medical, Inc.Devices06/14/2023Personnel
Footprint Medical, Inc.Devices06/14/2023Design verification - Lack of or inadequate procedures
Footprint Medical, Inc.Devices06/14/2023Incorrect translation to production specifications
Footprint Medical, Inc.Devices06/14/2023Production processes
Footprint Medical, Inc.Devices06/14/2023Software validation for automated processes
Footprint Medical, Inc.Devices06/14/2023Lack of or inadequate process validation
Footprint Medical, Inc.Devices06/14/2023Lack of or inadequate procedures
Footprint Medical, Inc.Devices06/14/2023Statistical techniques - Lack of or inadequate procedures
Germaine Laboratories, Inc.Devices09/27/2023Quality audits - Lack of or inadequate procedures
Germaine Laboratories, Inc.Devices09/27/2023Documentation
Germaine Laboratories, Inc.Devices09/27/2023Lack of or inadequate procedures
Germaine Laboratories, Inc.Devices09/27/2023DHR content
Germaine Laboratories, Inc.Devices09/27/2023Statistical techniques - Lack of or inadequate procedures
LA Aldea Distributors, Inc.Food and Cosmetics08/11/2023Develop FSVP
Magaya FoodsFood and Cosmetics03/09/2023Develop FSVP
Mega PG DistributionsFood and Cosmetics04/11/2023Develop FSVP
Mesquite Gourmet, LLCFood and Cosmetics07/20/2023Develop FSVP
Mesquite Gourmet, LLCFood and Cosmetics07/20/2023Identification - entry
NBF Distributions, Inc.Food and Cosmetics01/30/2023Develop FSVP
Texas Fertility CenterBiologics06/21/2023Risk factors, clinical evidence
Tiller MIND BODY, Inc.Devices07/13/2023Lack of or inadequate final acceptance procedures
Tiller MIND BODY, Inc.Devices07/13/2023Lack of or inadequate DHR procedures
Tiller MIND BODY, Inc.Devices07/13/2023Lack of or inadequate complaint procedures
UT Health San Antonio Reproductive Health and Fertility CenterBiologics01/06/2023Determination based on screening and testing
Ultra International DistributorsFood and Cosmetics12/04/2023Develop FSVP
Ultra International DistributorsFood and Cosmetics12/04/2023Verification activity - appropriate
Ultra International DistributorsFood and Cosmetics12/04/2023Identification - entry
Ultra International DistributorsFood and Cosmetics12/04/2023Record - translate to English
World Green Nutrition, Inc.Food and Cosmetics05/30/2023Develop FSVP
XENEX Disinfection Services, Inc.Devices10/31/2023Quality audits - Lack of or inadequate procedures
XENEX Disinfection Services, Inc.Devices10/31/2023Design changes - Lack of or Inadequate Procedures
XENEX Disinfection Services, Inc.Devices10/31/2023Software validation for automated processes
XENEX Disinfection Services, Inc.Devices10/31/2023Lack of or inadequate procedures
XENEX Disinfection Services, Inc.Devices10/31/2023DMR - not or inadequately maintained
XENEX Disinfection Services, Inc.Devices10/31/2023Lack of or inadequate complaint procedures

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