FDA 483 - Modus Health, LLC - May 10, 2023

Modus Health, LLC in Edmonds, WA was inspected from May 9-10, 2023, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's procedures for controlling non-conforming products and for establishing adequate corrective and preventive actions. These issues indicate a need for improved quality system controls.