Mid City Times

There were seven companies in cities associated with Denton County that received FDA citations as a result of seven 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 65% 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 either Food and Cosmetics, Devices, or Drugs sectors.

All of the companies cited should take voluntary actions to correct their managing operations.

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
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
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
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
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