FDA 483 - POM Medical LLC - March 08, 2022

POM Medical, LLC, a medical device manufacturer in Moorpark, CA, was inspected and cited for inadequate procedures to control non-conforming products. The inspection revealed failures in documenting material review board activities, completing non-conforming product forms, and documenting rework activities. These issues indicate deficiencies in the firm's quality system for managing products that do not meet specified requirements.