The FDA website indicates that the citations were delivered to the company as follows:
'Validation of device software is inadequate.'
'Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.'
'Procedures for finished device acceptance 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.
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