FDA 483 - Nuclein LLC - January 13, 2026

Nuclein LLC, a manufacturer of Class II medical devices in Austin, TX, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate investigation of device complaints and medical device reporting evaluations, insufficient risk analysis for potential harms like delayed treatment, and sampling plans for final product acceptance testing that lacked valid statistical rationale. These issues indicate a need for comprehensive improvements in the firm's quality management system.