The FDA website indicates that the citations were delivered to the company as follows:
'Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.'
'A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.'
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.