FDA 483 - CivaTech Oncology Inc. - June 14, 2023

CivaTech Oncology Inc. in Morrisville, NC, was inspected and received a Form FDA 483 with four observations related to its CivaString sterile implantable Class II medical device. The observations highlight deficiencies in risk analysis (a repeat finding), design input documentation, device history record maintenance, and finished device acceptance procedures. These issues indicate significant concerns with the firm's quality system for medical device manufacturing.