NE Dallas News

There were 44 companies in cities associated with Dallas County that received FDA citations as a result of 44 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 10% increase over the number of companies cited in the previous year.

Of the 126 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, 40 should take voluntary actions to correct their managing operations (90.9%). Additionally, five companies had to take regulatory and/or administrative actions (11.4%).

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
AVEM Medical, LLC	Biologics	05/18/2023	Written calibration / inspection records not kept
AVEM Medical, LLC	Biologics	05/18/2023	Storage under appropriate conditions
AVEM Medical, LLC	Biologics	05/18/2023	Storage temperatures appropriate
All For Your Cakes, Inc.	Food and Cosmetics	08/28/2023	Very small importer assurances, supplier
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
Aspire Fertility Institute Dallas	Biologics	07/12/2023	Determination based on screening and testing
Aspire Fertility Institute Dallas	Biologics	07/12/2023	Statement re: certified testing lab
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
Dart Container Corporation	Food and Cosmetics	08/25/2023	Hazard analysis written
Dart Container Corporation	Food and Cosmetics	08/25/2023	Evaluation - performance, risk
Dart Container Corporation	Food and Cosmetics	08/25/2023	Verification activity assurance
Dart Container Corporation	Food and Cosmetics	08/25/2023	Verification activity before import, periodically
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - component identity
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - identity, purity, strength, composition
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Component - verify identity, dietary ingredient
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Documentation - qualify supplier
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
Fruit Of The Earth Research Laboratories, Inc.	Drugs	03/31/2023	Buildings not maintained in good state of repair
Genesis Biosystems, Inc.	Devices	01/09/2023	Quality audits - auditor independence
Genesis Biosystems, Inc.	Devices	01/09/2023	Acceptable supplier records, inadequate records
Genesis Biosystems, Inc.	Devices	01/09/2023	Lack of or inadequate complaint procedures
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
InReach Convenient Solutions	Food and Cosmetics	03/06/2023	Pest control
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
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Handling harvested produce
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Treat seed with a scientifically valid method
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Sanitary food contact surfaces
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Environmental testing requirements
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Testing spent irrigation water
Korean Food, Inc.	Food and Cosmetics	08/25/2023	Personnel
La Fabrica, LLC	Food and Cosmetics	11/06/2023	Manufacturing, processing, packing, holding - Controls
Marriott International, Inc.	Food and Cosmetics	11/13/2023	Identification - entry
Marriott International, Inc.	Food and Cosmetics	11/13/2023	Regulatory oversight
Mary Kay, Inc.	Drugs	10/27/2023	Cleaning SOPs/equipment protection
Melinda's Foods, LLC	Food and Cosmetics	01/12/2023	Personnel
Mission Produce, Inc.	Food and Cosmetics	06/06/2023	Sanitary facilities and controls
Orthofix U. S., LLC	Devices	03/17/2023	Lack of or inadequate procedures
Orthofix U. S., LLC	Devices	03/17/2023	Investigation of device failures
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
Scott R. Bartley, M.D.	Drugs	02/17/2023	FD-1572, protocol compliance
Select Corporation	Drugs	09/14/2023	Procedures To Be in Writing
Select Corporation	Drugs	09/14/2023	Review of problem drugs
Select Corporation	Drugs	09/14/2023	No written record of investigation
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Written procedures - cleaning
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Written procedures - pest control
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Reserve sample - collect, hold
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Written procedures - holding
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Hold - temperature, humidity, light
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Records - returned dietary supplement: written procedures
Selery Fulfillment, Inc.	Food and Cosmetics	04/12/2023	Record - product complaint; batch, lot, control number
SouQ El Sudan, Inc.	Food and Cosmetics	09/08/2023	Develop FSVP
Taka USA, Inc.	Drugs	02/07/2023	Procedures not in writing, fully followed
Taka USA, Inc.	Drugs	02/07/2023	Training--operations, GMPs, written procedures
Taka USA, Inc.	Drugs	02/07/2023	Written procedures fail to include
Taka USA, Inc.	Drugs	02/07/2023	Reports of Analysis (Components)
Taka USA, Inc.	Drugs	02/07/2023	Control procedures to monitor and validate performance
Taka USA, Inc.	Drugs	02/07/2023	Scientifically sound laboratory controls
Taka USA, Inc.	Drugs	02/07/2023	Testing and release for distribution
Taka USA, Inc.	Drugs	02/07/2023	Test methods
Taka USA, Inc.	Drugs	02/07/2023	Prepared for each batch, include complete information
Talia Foods, LLC	Food and Cosmetics	09/15/2023	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
Thomsons Importers & Exporters	Food and Cosmetics	04/14/2023	Develop FSVP
Tiger Sugar DFW, LLC	Food and Cosmetics	06/27/2023	Hazard analysis written
Tiger Sugar DFW, LLC	Food and Cosmetics	06/27/2023	Approved supplier procedures - importer established
Unifi Aviation, LLC	Food and Cosmetics	01/25/2023	Handling to avoid contamination
Wello, Inc.	Devices	06/21/2023	Design verification - documentation
Wello, Inc.	Devices	06/21/2023	Documented evaluation
Wello, Inc.	Devices	06/21/2023	Lack of or inadequate receiving acceptance procedures
Wello, Inc.	Devices	06/21/2023	Product rework documentation, DHR {see also 820.184}
Wello, Inc.	Devices	06/21/2023	Documentation
Wello, Inc.	Devices	06/21/2023	Lack of or inadequate DHR procedures
Wello, Inc.	Devices	06/21/2023	Service reports
Xochitl Gourmet Foods, LLC	Food and Cosmetics	01/25/2023	Pest control
Xochitl Gourmet Foods, LLC	Food and Cosmetics	01/25/2023	Human food by-product: Identifying as animal food
Yi Group, Inc.	Food and Cosmetics	09/15/2023	Develop FSVP