FDA 483 - Vipamat SARL - October 26, 2023

An FDA inspection of Vipamat SARL, a medical device manufacturer in Ploemeur, France, revealed significant deficiencies in their quality system. The firm failed to establish and maintain adequate procedures for medical device reporting, finished device acceptance, design changes, and control over purchased products and services. Additionally, device history records were not properly maintained for their Beach & All Terrain Hippocampe Wheelchair devices.