The FDA website indicates that the citations were delivered to the company as follows:
'The quality policy was/were not established by management with executive responsibility.'
'The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.'
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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