HealthDent'l LLC – FDA 483, Apr 9, 2026

HealthDent'l LLC, a medical device manufacturer in Plainfield, IL, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for design changes, product distribution, internal audits, supplier management, and compliance with Unique Device Identification (UDI) requirements. These issues indicate a lack of robust controls over critical aspects of medical device manufacturing and quality assurance.