San Antonio Corridor News

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Atlas Medical Holdings, Inc.	Biologics	09/21/2023	All core requirements covered in program
Atlas Medical Holdings, Inc.	Biologics	09/21/2023	Evaluation--microorganisms, damage
Blue Baja, LLC	Food and Cosmetics	03/03/2023	Written procedures - personnel qualifications
Blue Baja, LLC	Food and Cosmetics	03/03/2023	Written procedures - holding
Blue Baja, LLC	Food and Cosmetics	03/03/2023	Written procedures - returned dietary supplement
Blue Baja, LLC	Food and Cosmetics	03/03/2023	Written procedures - product complaint
C. T. Grocers, LLC	Food and Cosmetics	03/01/2023	Hazard analysis written
C. T. Grocers, LLC	Food and Cosmetics	03/01/2023	Verification activity before import, periodically
Dulces La Mejor, LLC	Food and Cosmetics	04/21/2023	Hazard analysis written
Dulces La Mejor, LLC	Food and Cosmetics	04/21/2023	Hazard analysis biological, chemical, physical
ErgoMed, Inc.	Devices	12/06/2023	Label to bear a unique device identifier
ErgoMed, Inc.	Devices	12/06/2023	Complaints
ErgoMed, Inc.	Devices	12/06/2023	Devices subject to device identification GUDID data submission requirements.
Footprint Medical, Inc.	Devices	06/14/2023	Personnel
Footprint Medical, Inc.	Devices	06/14/2023	Design verification - Lack of or inadequate procedures
Footprint Medical, Inc.	Devices	06/14/2023	Incorrect translation to production specifications
Footprint Medical, Inc.	Devices	06/14/2023	Production processes
Footprint Medical, Inc.	Devices	06/14/2023	Software validation for automated processes
Footprint Medical, Inc.	Devices	06/14/2023	Lack of or inadequate process validation
Footprint Medical, Inc.	Devices	06/14/2023	Lack of or inadequate procedures
Footprint Medical, Inc.	Devices	06/14/2023	Statistical techniques - Lack of or inadequate procedures
Germaine Laboratories, Inc.	Devices	09/27/2023	Quality audits - Lack of or inadequate procedures
Germaine Laboratories, Inc.	Devices	09/27/2023	Documentation
Germaine Laboratories, Inc.	Devices	09/27/2023	Lack of or inadequate procedures
Germaine Laboratories, Inc.	Devices	09/27/2023	DHR content
Germaine Laboratories, Inc.	Devices	09/27/2023	Statistical techniques - Lack of or inadequate procedures
LA Aldea Distributors, Inc.	Food and Cosmetics	08/11/2023	Develop FSVP
Magaya Foods	Food and Cosmetics	03/09/2023	Develop FSVP
Mega PG Distributions	Food and Cosmetics	04/11/2023	Develop FSVP
Mesquite Gourmet, LLC	Food and Cosmetics	07/20/2023	Develop FSVP
Mesquite Gourmet, LLC	Food and Cosmetics	07/20/2023	Identification - entry
NBF Distributions, Inc.	Food and Cosmetics	01/30/2023	Develop FSVP
Texas Fertility Center	Biologics	06/21/2023	Risk factors, clinical evidence
Tiller MIND BODY, Inc.	Devices	07/13/2023	Lack of or inadequate final acceptance procedures
Tiller MIND BODY, Inc.	Devices	07/13/2023	Lack of or inadequate DHR procedures
Tiller MIND BODY, Inc.	Devices	07/13/2023	Lack of or inadequate complaint procedures
UT Health San Antonio Reproductive Health and Fertility Center	Biologics	01/06/2023	Determination based on screening and testing
Ultra International Distributors	Food and Cosmetics	12/04/2023	Develop FSVP
Ultra International Distributors	Food and Cosmetics	12/04/2023	Verification activity - appropriate
Ultra International Distributors	Food and Cosmetics	12/04/2023	Identification - entry
Ultra International Distributors	Food and Cosmetics	12/04/2023	Record - translate to English
World Green Nutrition, Inc.	Food and Cosmetics	05/30/2023	Develop FSVP
XENEX Disinfection Services, Inc.	Devices	10/31/2023	Quality audits - Lack of or inadequate procedures
XENEX Disinfection Services, Inc.	Devices	10/31/2023	Design changes - Lack of or Inadequate Procedures
XENEX Disinfection Services, Inc.	Devices	10/31/2023	Software validation for automated processes
XENEX Disinfection Services, Inc.	Devices	10/31/2023	Lack of or inadequate procedures
XENEX Disinfection Services, Inc.	Devices	10/31/2023	DMR - not or inadequately maintained
XENEX Disinfection Services, Inc.	Devices	10/31/2023	Lack of or inadequate complaint procedures