NEW LIFE DIAGNOSTICS LLC – FDA 483, Apr 2, 2026

An FDA inspection of NEW LIFE DIAGNOSTICS, Inc. in Carlsbad, CA, a manufacturer of parasitology ELISA test kits, revealed significant deficiencies in their quality system. The firm failed to adequately document a system for Unique Device Identification (UDI) and had not submitted required UDI data to the GUDID database for Class I devices. Additionally, the inspection found that the firm's corrective and preventive action (CAPA) procedures were inadequate, with numerous instances of nonconformances and recurring issues not leading to CAPA initiation or effective resolution.