The FDA website indicates that the citations were delivered to the company as follows:
'An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.'
'Personnel training is not documented.'
'Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.'
'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.'
'Corrective and preventive action activities and/or results have not been adequately documented.'
'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.
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