The FDA website indicates that the citations were delivered to the company as follows:
'Design validation did not ensure the device conforms to defined user needs and intended uses.'
'Acceptance criteria were not established prior to the performance of validation activities.'
'Procedures for acceptance of incoming product have not been adequately established.'
'Procedures have not been adequately established to control product that does not conform to specified requirements.'
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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