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North Jefferson County News

Wednesday, November 6, 2024

FDA: 3 companies in cities within Jefferson County received 20 citations in 2023

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

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

This is a 50% increase over the number of companies cited in the previous year.

Of the 20 citations issued, the most common citations were 'You did not establish and follow written procedures for holding and distributing operations' and 'You did not establish and follow written procedures for the requirements to review and investigate a product complaint'.

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

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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 Jefferson County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Allison Medical, Inc.Devices04/28/2023Files do not contain copies of MDR reports
Allison Medical, Inc.Devices04/28/2023Procedures not adequately established or maintained
Allison Medical, Inc.Devices04/28/2023Software validation for automated processes
Allison Medical, Inc.Devices04/28/2023Lack of or inadequate procedures
Osmosis, LLCFood and Cosmetics01/13/2023Procedures - equipment - cleaning, sanitizing
Osmosis, LLCFood and Cosmetics01/13/2023Specifications - component identity
Osmosis, LLCFood and Cosmetics01/13/2023Specifications-component purity, strength, composition
Osmosis, LLCFood and Cosmetics01/13/2023Specifications - identity, purity, strength, composition
Osmosis, LLCFood and Cosmetics01/13/2023Component - qualify supplier
Osmosis, LLCFood and Cosmetics01/13/2023Written procedures - quality control operations
Osmosis, LLCFood and Cosmetics01/13/2023Master manufacturing record - unique formulation
Osmosis, LLCFood and Cosmetics01/13/2023Batch record - complete
Osmosis, LLCFood and Cosmetics01/13/2023Batch record - quality control review; production
Osmosis, LLCFood and Cosmetics01/13/2023Written procedures - holding
Osmosis, LLCFood and Cosmetics01/13/2023Written procedures returned dietary supplement investigation
Osmosis, LLCFood and Cosmetics01/13/2023Written procedures - product complaint
Wild Warrior Nutrition, LLCFood and Cosmetics07/14/2023Written procedure quality control operations material review
Wild Warrior Nutrition, LLCFood and Cosmetics07/14/2023Written procedures - holding
Wild Warrior Nutrition, LLCFood and Cosmetics07/14/2023Records - returned dietary supplement: written procedures
Wild Warrior Nutrition, LLCFood and Cosmetics07/14/2023Written procedures - product complaint

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