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Thursday, October 31, 2024

How many companies in cities across Parker County received FDA citations in 2023?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

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

This is a 100% increase over the number of companies cited in the previous year.

Of the 21 citations issued, the most common citations were 'You did not establish written procedures to ensure that you import foods only from approved foreign suppliers' and 'You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food'.

Most of the companies cited were involved in the Food and Cosmetics sector.

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.

Companies Located Within Parker County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
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
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
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
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
Mtek Group, LLCFood and Cosmetics09/27/2023Approved supplier procedures - importer established
Premier Produce ServicesFood and Cosmetics05/02/2023Supplier approval - document
Premier Produce ServicesFood and Cosmetics05/02/2023Onsite audit
Renfro Foods, Inc.Food and Cosmetics08/31/2023Process deviation
Renfro Foods, Inc.Food and Cosmetics08/31/2023Qualifications of individuals

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