FDA 483 - Prollenium Medical Technologies Inc. - November 09, 2023

An FDA inspection of Prollenium Medical Technologies Inc. in Richmond Hill, a manufacturer of class III dermal fillers, revealed significant deficiencies in its quality system. The firm was cited for inadequate process validation, insufficient in-process product control, and flawed risk analysis for its Revanesse products. Additionally, issues were identified with the establishment and control of acceptable suppliers and contractors.