West Arapahoe News

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

This is unchanged from the number of companies cited in the previous year.

Of the 20 citations issued, the most common citation was 'Document control procedures have not been adequately established'.

Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the the Biologics 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
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
AlloSource	Biologics	03/30/2023	Clean, sanitary, orderly manner
AlloSource	Biologics	03/30/2023	Validation & approval--established procedures
CoRE labs, LLC	Devices	06/21/2023	Design changes - Lack of or Inadequate Procedures
CoRE labs, LLC	Devices	06/21/2023	Procedures not adequately established or maintained
CoRE labs, LLC	Devices	06/21/2023	Nonconforming product, Lack of or inadequate procedures
CoRE labs, LLC	Devices	06/21/2023	Lack of or inadequate complaint procedures
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
Share Good Foods, Inc.	Food and Cosmetics	02/23/2023	Qualifications of individuals
Share Good Foods, Inc.	Food and Cosmetics	02/23/2023	Personnel
Share Good Foods, Inc.	Food and Cosmetics	02/23/2023	Cleaning and sanitizing substances - Safe and adequate
Share Good Foods, Inc.	Food and Cosmetics	02/23/2023	Pest control
Share Good Foods, Inc.	Food and Cosmetics	02/23/2023	Manufacturing, processing, packing, holding - Controls