The FDA website indicates that the citations were delivered to the company as follows:
'Failure to assure that personnel have capabilities commensurate with, the necessary training in, necessary experience in and a thorough understanding of the operations which they perform.'
'Written standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood and blood components for allogeneic transfusion, autologous transfusion and further manufacturing purposes were not always established, maintained and followed.'
'The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.'
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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