East Arapahoe News

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

This is a 33.3% increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not establish and follow written procedures for quality control operations for conducting a material review and making a disposition decision.
• You did not establish and follow written procedures for holding and distributing operations.
• You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Amalgamated Sugar Company, LLC	Food and Cosmetics	03/20/2023	Pest control
D. O. Weaver and Company	Devices	05/12/2023	Lack of or inadequate process validation
D. O. Weaver and Company	Devices	05/12/2023	Records of MDR Investigation
Lewis, Karl D., M.D.	Biologics	08/07/2023	Copy of consent form not provided
Lewis, Karl D., M.D.	Biologics	08/07/2023	FD-1572, protocol compliance
Lewis, Karl D., M.D.	Biologics	08/07/2023	Case history records- inadequate or inadequate
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