Se Denver News

There was one company in a city associated with Boulder County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Records of acceptable suppliers and contractors have not been adequately established.
• Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.

The company cited should take a voluntary action to correct its 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
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