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FDA issued 18 citations in cities across Fort Bend County in Q4 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

There were eight companies in cities associated with Fort Bend 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 38.5% decrease from the number of companies cited in the previous quarter.

Of the 18 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.

Of the companies cited, four should take voluntary actions to correct their managing operations (50%). Additionally, three companies had to take regulatory and/or administrative actions (37.5%).

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 Fort Bend County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Aracely Express, Inc.Food and Cosmetics11/20/2023Written procedures - pest control
Aracely Express, Inc.Food and Cosmetics11/20/2023Reserve sample - collect, hold
Aracely Express, Inc.Food and Cosmetics11/20/2023Written procedures - holding
Aracely Express, Inc.Food and Cosmetics11/20/2023Records - returned dietary supplement: written procedures
Aracely Express, Inc.Food and Cosmetics11/20/2023Written procedures - product complaint; review, investigate
Himalaya Wellness USA, Ltd.Food and Cosmetics12/05/2023Written procedure quality control operations material review
Himalaya Wellness USA, Ltd.Food and Cosmetics12/05/2023QC operations - packaged, labeled; specifications
Meditco, Inc.Food and Cosmetics11/15/2023Develop FSVP
Mega Harvest CorporationFood and Cosmetics10/25/2023Develop FSVP
Minland of Texas, Inc.Food and Cosmetics10/06/2023Develop FSVP
Regino Produce, LLCFood and Cosmetics10/27/2023Develop FSVP
Seatex, LLCDrugs10/20/2023Procedures not in writing, fully followed
Seatex, LLCDrugs10/20/2023Written procedures not established/followed
Seatex, LLCDrugs10/20/2023Control procedures to monitor and validate performance
Seatex, LLCDrugs10/20/2023Expiration date lacking
Seatex, LLCDrugs10/20/2023Scientifically sound laboratory controls
Seatex, LLCDrugs10/20/2023Complete test data included in records
Walker Coffee Trading, L. P.Food and Cosmetics10/16/2023Hazard analysis written

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