FDA 483 - Arch - MedTorque Inc. - December 15, 2023

Arch - MedTorque Inc. in Kenosha, WI, a medical device manufacturer, received a Form FDA 483 for significant quality system deficiencies. The inspection revealed inadequate documentation of corrective and preventive action (CAPA) activities and results, along with inadequately established CAPA procedures. Additionally, the firm's organizational structure was found to be inconsistent with its quality manual regarding key management roles.