FDA 483 - ONCORE - SAN MARCOS dba NEOTECH - March 06, 2020

An FDA inspection of ORTHOCORE - SAN MARCOS dba NEOTECH, a contract manufacturer in San Marcos, CA, revealed three observations. The firm was cited for inadequately maintaining complaint files, failing to establish adequate process control procedures, and not properly controlling nonconforming products. These issues indicate deficiencies in documentation and adherence to established manufacturing processes.