Se Denver News

There were three companies in cities associated with Boulder 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 40% decrease from the number of companies cited in the previous year.

Of the nine citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

All of the companies cited were involved in the Devices 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
Arthur R. Cabrera, M.D.	Devices	05/16/2023	Circumstances of obtaining consent
Arthur R. Cabrera, M.D.	Devices	05/16/2023	Abbreviated requirements / non-significant risk study
Arthur R. Cabrera, M.D.	Devices	05/16/2023	Label does not contain required information
Boulder Biomed	Devices	10/30/2023	Acceptable supplier records, inadequate records
Boulder Biomed	Devices	10/30/2023	Process control procedures, Lack of or inadequate procedures
Boulder Biomed	Devices	10/30/2023	Lack of or inadequate process validation
Boulder Biomed	Devices	10/30/2023	Nonconforming product, Lack of or inadequate procedures
Boulder Biomed	Devices	10/30/2023	Lack of or inadequate procedures
Tensentric, LLC	Devices	04/14/2023	Lack of or inadequate procedures