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Wednesday, November 20, 2024

FDA: 22 companies in cities within Rockwall County received 62 citations in 2023

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

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.

Companies Located Within Rockwall 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
AjitSingh, LLCFood and Cosmetics06/26/2023Develop FSVP
American Chinese Natural Herbs, Inc.Food and Cosmetics08/14/2023Equipment - automated - calibrate, inspect
American Chinese Natural Herbs, Inc.Food and Cosmetics08/14/2023Specifications - labels, packaging
American Chinese Natural Herbs, Inc.Food and Cosmetics08/14/2023Component - qualify supplier
American Chinese Natural Herbs, Inc.Food and Cosmetics08/14/2023Specifications met - verify; production, process control
American Chinese Natural Herbs, Inc.Food and Cosmetics08/14/2023Records - returned dietary supplement: written procedures
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
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
Carrollclean, LLCDrugs08/31/2023SOPs not followed / documented
Carrollclean, LLCDrugs08/31/2023Test devices not meeting specifications
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
El Gordo Spices, LLCFood and Cosmetics03/22/2023Hazard analysis - Conducted
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
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
La Fabrica, LLCFood and Cosmetics11/06/2023Manufacturing, processing, packing, holding - Controls
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
RP Foods, LLCFood and Cosmetics07/06/2023Develop FSVP
SouQ El Sudan, Inc.Food and Cosmetics09/08/2023Develop FSVP
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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