Eurofins Viracor, Inc. in Lees Summit, Missouri was inspected by the Food and Drug Administration (FDA) on July 26 for post-market assurance for devices and received four citations, according to data posted on the FDA’s official website.
The FDA website indicates that the citations were delivered to the company as follows:
‘Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.’
‘Procedures for the acceptance of in-process product have not been adequately established.’
‘Procedures have not been adequately established to control product that does not conform to specified requirements.’
‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.’
The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.
The FDA is a government agency that is primarily responsible for monitoring the manufacturing and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
