FDA 483 - Nuclein LLC - January 13, 2026

An FDA inspection of Nuclein LLC in Austin, TX, a manufacturer of a Class II medical device for diagnosing respiratory viruses, revealed significant quality system deficiencies. The firm failed to adequately investigate device complaints, particularly those involving invalid results and motor errors, due to flawed internal thresholds. Additionally, the inspection found inadequate risk analysis for hazards like delayed results leading to delayed treatment, and sampling plans for final acceptance testing lacked valid statistical rationale.