FDA 483 - Hospital Therapy Products Inc. - May 14, 2019

Hospital Therapy Products Inc. in Wood Dale, IL, was inspected by the FDA from May 7-14, 2019, and received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in establishing quality audits, documenting CAPA activities, defining quality policy and plans, establishing management review procedures, and ensuring proper document control. Several observations were repeats from previous inspections, indicating persistent issues.