Anacom General Corp. (doing business as Anacom Medtek) in Anaheim, California was inspected by the Food and Drug Administration (FDA) on July 12 for post-market assurance for devices and received nine 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:
‘Written MDR procedures have not been developed, maintained and implemented.’
‘Procedures for training and identifying training needs have not been established.’
‘Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.’
‘Procedures for acceptance of incoming product have not been adequately established.’
‘Procedures for finished device acceptance have not been established.’
‘Procedures have not been adequately established to control product that does not conform to specified requirements.’
‘Procedures for corrective and preventive action have not been adequately established.’
‘The device history record does not demonstrate that the device was manufactured in accordance with the device master record.’
‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit 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.
