Helio USA Inc – FDA 483, Sep 26, 2011

Helio Medical Supplies Inc. in San Jose, CA, was inspected and cited for significant deficiencies across its quality system. The inspection revealed a lack of established procedures for design control, complaint handling, corrective and preventive actions, and purchasing controls. Additionally, issues with supplier agreements, incoming product acceptance, document control, and personnel training were identified, indicating a systemic breakdown in quality management for their medical devices, including acupuncture needles and infrared heat lamps.