West Arapahoe News

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Allison Medical, Inc.	Devices	04/28/2023	Files do not contain copies of MDR reports
Allison Medical, Inc.	Devices	04/28/2023	Procedures not adequately established or maintained
Allison Medical, Inc.	Devices	04/28/2023	Software validation for automated processes
Allison Medical, Inc.	Devices	04/28/2023	Lack of or inadequate procedures
Osmosis, LLC	Food and Cosmetics	01/13/2023	Procedures - equipment - cleaning, sanitizing
Osmosis, LLC	Food and Cosmetics	01/13/2023	Specifications - component identity
Osmosis, LLC	Food and Cosmetics	01/13/2023	Specifications-component purity, strength, composition
Osmosis, LLC	Food and Cosmetics	01/13/2023	Specifications - identity, purity, strength, composition
Osmosis, LLC	Food and Cosmetics	01/13/2023	Component - qualify supplier
Osmosis, LLC	Food and Cosmetics	01/13/2023	Written procedures - quality control operations
Osmosis, LLC	Food and Cosmetics	01/13/2023	Master manufacturing record - unique formulation
Osmosis, LLC	Food and Cosmetics	01/13/2023	Batch record - complete
Osmosis, LLC	Food and Cosmetics	01/13/2023	Batch record - quality control review; production
Osmosis, LLC	Food and Cosmetics	01/13/2023	Written procedures - holding
Osmosis, LLC	Food and Cosmetics	01/13/2023	Written procedures returned dietary supplement investigation
Osmosis, LLC	Food and Cosmetics	01/13/2023	Written procedures - product complaint
Wild Warrior Nutrition, LLC	Food and Cosmetics	07/14/2023	Written procedure quality control operations material review
Wild Warrior Nutrition, LLC	Food and Cosmetics	07/14/2023	Written procedures - holding
Wild Warrior Nutrition, LLC	Food and Cosmetics	07/14/2023	Records - returned dietary supplement: written procedures
Wild Warrior Nutrition, LLC	Food and Cosmetics	07/14/2023	Written procedures - product complaint