East DFW News

There were 22 companies in cities associated with Rockwall County that received FDA citations as a result of 22 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 22.2% increase over the number of companies cited in the previous year.

Of the 62 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 Drugs sector.

Of the companies cited, 20 should take voluntary actions to correct their managing operations (90.9%). Additionally, two companies had to take regulatory and/or administrative actions (9.1%).

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
ARG Laboratories, Inc.	Drugs	09/20/2023	Lack of quality control unit
ARG Laboratories, Inc.	Drugs	09/20/2023	Reports of Analysis (Components)
ARG Laboratories, Inc.	Drugs	09/20/2023	Retest of approved components/containers/closures
ARG Laboratories, Inc.	Drugs	09/20/2023	Control procedures to monitor and validate performance
ARG Laboratories, Inc.	Drugs	09/20/2023	Expiration date lacking
ARG Laboratories, Inc.	Drugs	09/20/2023	Scientifically sound laboratory controls
ARG Laboratories, Inc.	Drugs	09/20/2023	Failing drug products not rejected
AjitSingh, LLC	Food and Cosmetics	06/26/2023	Develop FSVP
American Chinese Natural Herbs, Inc.	Food and Cosmetics	08/14/2023	Equipment - automated - calibrate, inspect
American Chinese Natural Herbs, Inc.	Food and Cosmetics	08/14/2023	Specifications - labels, packaging
American Chinese Natural Herbs, Inc.	Food and Cosmetics	08/14/2023	Component - qualify supplier
American Chinese Natural Herbs, Inc.	Food and Cosmetics	08/14/2023	Specifications met - verify; production, process control
American Chinese Natural Herbs, Inc.	Food and Cosmetics	08/14/2023	Records - returned dietary supplement: written procedures
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Quality audits - auditor independence
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Procedures not adequately established or maintained
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Purchasing controls, Lack of or inadequate procedures
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Lack of or inadequate final acceptance procedures
Anesthetic Gas Reclamation, Inc.	Devices	05/04/2023	Lack of or inadequate complaint procedures
Beverage King, LLC	Food and Cosmetics	07/13/2023	Manufacturing, processing, packing, holding - Controls
Beverage King, LLC	Food and Cosmetics	07/13/2023	All hazards not considered
Beverage King, LLC	Food and Cosmetics	07/13/2023	Calibration, testing - no records
Beverage King, LLC	Food and Cosmetics	07/13/2023	Records - actual values
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - monitoring procedures - none listed
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - corrective action plan not included
Carrollclean, LLC	Drugs	08/31/2023	SOPs not followed / documented
Carrollclean, LLC	Drugs	08/31/2023	Test devices not meeting specifications
Colgin, Inc.	Drugs	09/21/2023	Procedures not in writing, fully followed
Colgin, Inc.	Drugs	09/21/2023	Cleaning / Sanitizing / Maintenance
Colgin, Inc.	Drugs	09/21/2023	Identity Testing of Each Component
Colgin, Inc.	Drugs	09/21/2023	Actual vs. theoretical yields not determined
Colgin, Inc.	Drugs	09/21/2023	Testing and release for distribution
Creative Liquids, LLC	Food and Cosmetics	07/20/2023	Instruments - calibration
El Gordo Spices, LLC	Food and Cosmetics	03/22/2023	Hazard analysis - Conducted
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Donor testing not negative for CD agents
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Documentation--determination, by whom, date
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Risk factors, clinical evidence
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Eligibility not required--warning labels
Grain Market, LLC	Food and Cosmetics	07/10/2023	Hazard analysis written
Grain Market, LLC	Food and Cosmetics	07/10/2023	Evaluation - performance, risk
Grain Market, LLC	Food and Cosmetics	07/10/2023	Approved supplier procedures - importer established
Grain Market, LLC	Food and Cosmetics	07/10/2023	Verification activity frequency
Grain Market, LLC	Food and Cosmetics	07/10/2023	Verification activity - appropriate
Grain Market, LLC	Food and Cosmetics	07/10/2023	Verification activity before import, periodically
Hiland Dairy Foods Company, LLC	Food and Cosmetics	08/04/2023	Sanitary operations - Plant sanitation
JMD, LLC	Food and Cosmetics	08/07/2023	Qualifications of individuals
JMD, LLC	Food and Cosmetics	08/07/2023	Pest control
JMD, LLC	Food and Cosmetics	08/07/2023	Record availability
La Fabrica, LLC	Food and Cosmetics	11/06/2023	Manufacturing, processing, packing, holding - Controls
Parvez Mantry	Drugs	11/14/2023	FD-1572, protocol compliance
Post Oak Innovations, Inc.	Devices	10/13/2023	Document change records, maintained.
Post Oak Innovations, Inc.	Devices	10/13/2023	Acceptable supplier records, inadequate records
Post Oak Innovations, Inc.	Devices	10/13/2023	Lack of or inadequate procedures
RP Foods, LLC	Food and Cosmetics	07/06/2023	Develop FSVP
SouQ El Sudan, Inc.	Food and Cosmetics	09/08/2023	Develop FSVP
Third Coast Marketing Holdings, LP	Food and Cosmetics	08/03/2023	Written procedures - quality control operations
Third Coast Marketing Holdings, LP	Food and Cosmetics	08/03/2023	Written procedures - holding
Third Coast Marketing Holdings, LP	Food and Cosmetics	08/03/2023	Written procedures - returned dietary supplement
Third Coast Marketing Holdings, LP	Food and Cosmetics	08/03/2023	Written procedures - product complaint
Third Coast Marketing Holdings, LP	Food and Cosmetics	08/03/2023	Quality control operations - packaging, labeling; approving, rejecting
Unifi Aviation, LLC	Food and Cosmetics	01/25/2023	Handling to avoid contamination
Yi Group, Inc.	Food and Cosmetics	09/15/2023	Develop FSVP