FDA 483 - INDUCTION THERAPIES LLC - March 21, 2019

An FDA inspection of INDUCTION THERAPIES LLC in Louisville, KY, revealed significant deficiencies in the firm's quality system. The company failed to establish a quality policy, quality objectives, and a comprehensive quality plan. Furthermore, critical quality system procedures for areas such as management review, quality audits, CAPA, complaint handling, acceptance activities, and purchasing controls were either not developed or not implemented.