Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 3.1% increase over the number of companies cited in the previous year.
Of the 91 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, 30 should take voluntary actions to correct their managing operations (90.9%). Additionally, three 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 Collin County Cities and the Citations They Received in 2023
| 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 |
| Cookies-n-Milk, LLC | Food and Cosmetics | 10/19/2023 | Hazard analysis - Identification of hazard |
| Cookies-n-Milk, LLC | Food and Cosmetics | 10/19/2023 | Supply-chain program - Implement |
| Creative Liquids, LLC | Food and Cosmetics | 07/20/2023 | Instruments - calibration |
| Dentlight, Inc. | Devices | 08/23/2023 | Quality audits - auditor independence |
| 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 |
| Eminent Spine, LLC | Devices | 10/13/2023 | Info evaluated to determine if event was reportable |
| Eminent Spine, LLC | Devices | 10/13/2023 | Design Validation - Risk analysis not performed/inadequate |
| Eminent Spine, LLC | Devices | 10/13/2023 | Approval, inadequate purchasing data |
| 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 |
| First Fitness International, Inc. | Food and Cosmetics | 01/25/2023 | Quality control operations - packaged, labeled; specifications |
| Formulife, LLC | Food and Cosmetics | 01/30/2023 | Allergen preventive controls - Implement |
| 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 |
| Morgan Newton Comp. | Devices | 05/12/2023 | Product rework adverse effects {see also 820.184} |
| Morgan Newton Comp. | Devices | 05/12/2023 | DHR - not or inadequately maintained |
| 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 |
| The Magni Group, Inc. | Food and Cosmetics | 03/07/2023 | Specifications - contamination limits |
| The Magni Group, Inc. | Food and Cosmetics | 03/07/2023 | Specifications - identity, purity, strength, composition |
| The Magni Group, Inc. | Food and Cosmetics | 03/07/2023 | Written procedure quality control operations material review |
| The Magni Group, Inc. | Food and Cosmetics | 03/07/2023 | Written procedures - returned dietary supplement |
| 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 |
Alerts Sign-up