FDA 483 - Taurus Engineering and Manufacturing, Inc. - December 04, 2018

Taurus Engineering and Manufacturing, Inc. in Saint Paul, MN, received a Form FDA-483 citing significant quality system deficiencies during an inspection. The firm failed to adequately validate critical injection molding processes for medical device components, resulting in products not meeting dimensional requirements and subsequent field failures. Additionally, the company lacked established process control procedures for molding parameters and adequate controls for in-process product acceptance and inspection.