FDA 483 - Bio Protech Usa, Inc. - February 20, 2020

An FDA inspection of Bio Protech Usa, Inc., a repackager/relabeler in Chino, CA, revealed significant deficiencies in their quality system. The firm failed to establish adequate written procedures for handling complaints, medical device reporting (MDR), and acceptance activities for finished products. Additionally, the inspection found a complete lack of established training procedures and documentation for personnel.