FDA 483 - VASTMED LLC - July 23, 2025

VASTMED LLC, a medical device manufacturer in Grand Prairie, TX, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacks established procedures for incoming product acceptance, nonconforming material control, and Medical Device Reporting (MDRs). Additionally, its medical device labels do not comply with Unique Device Identifier (UDI) regulations, and product information has not been registered with the GUDID.