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Thursday, October 31, 2024

FDA: 40 companies in cities within Denton County received 111 citations in 2023

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

There were 40 companies in cities associated with Denton County that received FDA citations as a result of 40 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 29% increase over the number of companies cited in the previous year.

Of the 111 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, 37 should take voluntary actions to correct their managing operations (92.5%). Additionally, three companies had to take regulatory and/or administrative actions (7.5%).

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 Denton County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
ARG Laboratories, Inc.Drugs09/20/2023Lack of quality control unit
ARG Laboratories, Inc.Drugs09/20/2023Reports of Analysis (Components)
ARG Laboratories, Inc.Drugs09/20/2023Retest of approved components/containers/closures
ARG Laboratories, Inc.Drugs09/20/2023Control procedures to monitor and validate performance
ARG Laboratories, Inc.Drugs09/20/2023Expiration date lacking
ARG Laboratories, Inc.Drugs09/20/2023Scientifically sound laboratory controls
ARG Laboratories, Inc.Drugs09/20/2023Failing drug products not rejected
All For Your Cakes, Inc.Food and Cosmetics08/28/2023Very small importer assurances, supplier
Amcor Rigid Packaging USA, LLCDevices01/12/2023Evaluation of suppliers, contractors, etc., requirements
Amcor Rigid Packaging USA, LLCDevices01/12/2023Nonconforming product, Lack of or inadequate procedures
Amcor Rigid Packaging USA, LLCDevices01/12/2023Lack of or inadequate complaint procedures
Anbar Distributions, LLCFood and Cosmetics08/17/2023Very small importer assurances, supplier
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Quality audits - auditor independence
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Procedures not adequately established or maintained
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Purchasing controls, Lack of or inadequate procedures
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Calibration, Inspection, etc. Procedures Lack of or Inadequ
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Lack of or inadequate final acceptance procedures
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Lack of or inadequate complaint procedures
Beverage King, LLCFood and Cosmetics07/13/2023Manufacturing, processing, packing, holding - Controls
Beverage King, LLCFood and Cosmetics07/13/2023All hazards not considered
Beverage King, LLCFood and Cosmetics07/13/2023Calibration, testing - no records
Beverage King, LLCFood and Cosmetics07/13/2023Records - actual values
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Supplier approval - document
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Approved supplier procedures - importer established
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Supplier verification - establish written procedures
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Record - English
Brian FlowersDrugs03/23/2023FD-1572, protocol compliance
Buda Juice, LLCFood and Cosmetics11/14/2023HACCP plan - monitoring procedures - none listed
Buda Juice, LLCFood and Cosmetics11/14/2023HACCP plan - corrective action plan not included
Colgin, Inc.Drugs09/21/2023Procedures not in writing, fully followed
Colgin, Inc.Drugs09/21/2023Cleaning / Sanitizing / Maintenance
Colgin, Inc.Drugs09/21/2023Identity Testing of Each Component
Colgin, Inc.Drugs09/21/2023Actual vs. theoretical yields not determined
Colgin, Inc.Drugs09/21/2023Testing and release for distribution
Creative Liquids, LLCFood and Cosmetics07/20/2023Instruments - calibration
Dentlight, Inc.Devices08/23/2023Quality audits - auditor independence
El Gordo Spices, LLCFood and Cosmetics03/22/2023Hazard analysis - Conducted
Eminent Spine, LLCDevices10/13/2023Info evaluated to determine if event was reportable
Eminent Spine, LLCDevices10/13/2023Design Validation - Risk analysis not performed/inadequate
Eminent Spine, LLCDevices10/13/2023Approval, inadequate purchasing data
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Donor testing not negative for CD agents
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Documentation--determination, by whom, date
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Risk factors, clinical evidence
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Eligibility not required--warning labels
First Fitness International, Inc.Food and Cosmetics01/25/2023Quality control operations - packaged, labeled; specifications
Genesis Biosystems, Inc.Devices01/09/2023Quality audits - auditor independence
Genesis Biosystems, Inc.Devices01/09/2023Acceptable supplier records, inadequate records
Genesis Biosystems, Inc.Devices01/09/2023Lack of or inadequate complaint procedures
Grain Market, LLCFood and Cosmetics07/10/2023Hazard analysis written
Grain Market, LLCFood and Cosmetics07/10/2023Evaluation - performance, risk
Grain Market, LLCFood and Cosmetics07/10/2023Approved supplier procedures - importer established
Grain Market, LLCFood and Cosmetics07/10/2023Verification activity frequency
Grain Market, LLCFood and Cosmetics07/10/2023Verification activity - appropriate
Grain Market, LLCFood and Cosmetics07/10/2023Verification activity before import, periodically
Hiland Dairy Foods Company, LLCFood and Cosmetics08/04/2023Sanitary operations - Plant sanitation
JMD, LLCFood and Cosmetics08/07/2023Qualifications of individuals
JMD, LLCFood and Cosmetics08/07/2023Pest control
JMD, LLCFood and Cosmetics08/07/2023Record availability
Lucid Wellness, LLCFood and Cosmetics02/17/2023Quality control - quality, dietary supplement
Lucid Wellness, LLCFood and Cosmetics02/17/2023Reserve sample - collect, hold
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - holding
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - returned dietary supplement
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - product complaint
Mannatech IncorporatedFood and Cosmetics09/13/2023Develop FSVP
Marriott International, Inc.Food and Cosmetics11/13/2023Identification - entry
Marriott International, Inc.Food and Cosmetics11/13/2023Regulatory oversight
Mary Kay, Inc.Drugs10/27/2023Cleaning SOPs/equipment protection
Mid-States Distributing, LLCVeterinary09/11/2023Document review entity's hazard analysis
Mid-States Distributing, LLCVeterinary09/11/2023Evaluation - performance, risk
Mid-States Distributing, LLCVeterinary09/11/2023Verification activity before import, periodically
Morgan Newton Comp.Devices05/12/2023Product rework adverse effects {see also 820.184}
Morgan Newton Comp.Devices05/12/2023DHR - not or inadequately maintained
Mtek Group, LLCFood and Cosmetics09/27/2023Approved supplier procedures - importer established
Orthofix U. S., LLCDevices03/17/2023Lack of or inadequate procedures
Orthofix U. S., LLCDevices03/17/2023Investigation of device failures
Parvez MantryDrugs11/14/2023FD-1572, protocol compliance
Post Oak Innovations, Inc.Devices10/13/2023Document change records, maintained.
Post Oak Innovations, Inc.Devices10/13/2023Acceptable supplier records, inadequate records
Post Oak Innovations, Inc.Devices10/13/2023Lack of or inadequate procedures
Premier Produce ServicesFood and Cosmetics05/02/2023Supplier approval - document
Premier Produce ServicesFood and Cosmetics05/02/2023Onsite audit
RP Foods, LLCFood and Cosmetics07/06/2023Develop FSVP
Renfro Foods, Inc.Food and Cosmetics08/31/2023Process deviation
Renfro Foods, Inc.Food and Cosmetics08/31/2023Qualifications of individuals
Select CorporationDrugs09/14/2023Procedures To Be in Writing
Select CorporationDrugs09/14/2023Review of problem drugs
Select CorporationDrugs09/14/2023No written record of investigation
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Written procedures - cleaning
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Written procedures - pest control
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Reserve sample - collect, hold
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Written procedures - holding
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Hold - temperature, humidity, light
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Records - returned dietary supplement: written procedures
Selery Fulfillment, Inc.Food and Cosmetics04/12/2023Record - product complaint; batch, lot, control number
SouQ El Sudan, Inc.Food and Cosmetics09/08/2023Develop FSVP
Taka USA, Inc.Drugs02/07/2023Procedures not in writing, fully followed
Taka USA, Inc.Drugs02/07/2023Training--operations, GMPs, written procedures
Taka USA, Inc.Drugs02/07/2023Written procedures fail to include
Taka USA, Inc.Drugs02/07/2023Reports of Analysis (Components)
Taka USA, Inc.Drugs02/07/2023Control procedures to monitor and validate performance
Taka USA, Inc.Drugs02/07/2023Scientifically sound laboratory controls
Taka USA, Inc.Drugs02/07/2023Testing and release for distribution
Taka USA, Inc.Drugs02/07/2023Test methods
Taka USA, Inc.Drugs02/07/2023Prepared for each batch, include complete information
Third Coast Marketing Holdings, LPFood and Cosmetics08/03/2023Written procedures - quality control operations
Third Coast Marketing Holdings, LPFood and Cosmetics08/03/2023Written procedures - holding
Third Coast Marketing Holdings, LPFood and Cosmetics08/03/2023Written procedures - returned dietary supplement
Third Coast Marketing Holdings, LPFood and Cosmetics08/03/2023Written procedures - product complaint
Third Coast Marketing Holdings, LPFood and Cosmetics08/03/2023Quality control operations - packaging, labeling; approving, rejecting
Unifi Aviation, LLCFood and Cosmetics01/25/2023Handling to avoid contamination
Yi Group, Inc.Food and Cosmetics09/15/2023Develop FSVP

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