FDA 483 - SoCal Healthy Hideway - April 29, 2022

SoCal Healthy Hideway, a manufacturer and specification developer in La Mesa, CA, was inspected by the FDA from April 25-29, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding design control, purchasing controls for software and services, and acceptance activities. These issues indicate a lack of established and documented procedures crucial for ensuring product quality and compliance.