FDA 483 - Millstone Medical Outsourcing, LLC - October 22, 2021

Millstone Medical Outsourcing, LLC in Fall River, MA, was inspected from October 5-22, 2021. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and utilize CAPAs for recurring problems with its automated cleaning systems and to verify the effectiveness of corrective actions.