Cook Biotech Incorporated in W Lafayette, Indiana was inspected by the Food and Drug Administration (FDA) on July 1 for human cellular, tissue, and gene therapies and received two citations, according to data posted on the FDA’s official website.
The FDA website indicates that the citations were delivered to the company as follows:
‘Investigation of deviations related to core CGTP requirements did not include efforts to determine the cause of the deviation.’
‘Records were not maintained concurrently with the performance of each step.’
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.
