FDA 483 - Integrity United Inc - September 25, 2025

Integrity United Inc, a specification developer in Anaheim, CA, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures and documentation for complaint handling, CAPA, purchasing controls, device history records, UDI labeling, design history files, document control, internal audits, and management review. Several observations were repeats from a previous inspection, indicating persistent systemic issues.