FDA 483 - Lantz Medical, Inc. - August 23, 2019

Kant> Medical, Inc. in Indianapolis, IN, was inspected and received a Form FDA 483 with seven observations related to significant deficiencies in their quality system. The inspection revealed inadequate procedures for complaint handling, CAPA, nonconforming product control, quality audits, and device history records. Additionally, the firm failed to document software validation and establish a design history file for their Vector 1 Hand Rehabilitation System.