FDA 483 - Integrity Dental Services LLC - June 30, 2025

Integrity Dental Services LLC in Duluth, GA, a manufacturer of dental restoration components, was cited with six observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for complaint handling, quality audits, employee training, equipment maintenance, supplier management, and document control. These issues indicate a broad lack of established and documented processes essential for regulatory compliance.