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How many FDA citations were issued in cities within Collin County in Q4 2023

Business

By Collin Times | Jan 21, 2024

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

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

This is a 46.7% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Donor testing of HCT/P donors considered eligible was not negative or nonreactive for relevant communicable disease agents.
  • Documentation of the donor-eligibility determination and the date of the donor-eligibility determination was not maintained.
  • Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.

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 .

Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).

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 Collin County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
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
Cookies-n-Milk, LLCFood and Cosmetics10/19/2023Hazard analysis - Identification of hazard
Cookies-n-Milk, LLCFood and Cosmetics10/19/2023Supply-chain program - Implement
Divine Design ManufacturingFood and Cosmetics11/21/2023Specifications - component identity
Divine Design ManufacturingFood and Cosmetics11/21/2023Specifications - identity, purity, strength, composition
Divine Design ManufacturingFood and Cosmetics11/21/2023Component - verify identity, dietary ingredient
Divine Design ManufacturingFood and Cosmetics11/21/2023Documentation - qualify supplier
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
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

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Organizations in this Story

City of GarlandCity of RichardsonCity of PlanoCity of Dallas

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