Currie Medical Specialties Inc in Franklin, Tennessee was inspected by the Food and Drug Administration (FDA) on July 11 for device compliance and received five 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:
‘Periodic inspections of equipment conducted to ensure adherence to applicable maintenance schedules were not documented.’
‘Procedures to ensure equipment is routinely calibrated have not been adequately established.’
‘A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.’
‘Procedures for acceptance activities have not been adequately established.’
‘Procedures for corrective and preventive action 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.
