FDA 483 - Nurse Assist, LLC - September 21, 2023

Nurse Assist, LLC received an FDA Form 483 citing significant deficiencies in their quality system, primarily focusing on inadequate validation of manufacturing processes for water-based medical devices. The observations highlight failures in controlling nonconforming products, implementing effective corrective and preventive actions, and maintaining proper environmental controls. The report also notes issues with equipment maintenance, supplier controls, and the timely reporting of adverse events.