FDA 483 - Integrity United Inc - October 18, 2021

An FDA inspection of Integrity United Inc in Anaheim, CA, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to establish a design history file for their B130C Home Care Bed and did not adequately document or verify corrective and preventive actions. These issues indicate a lack of adherence to quality system regulations for medical device manufacturing.