FDA 483 - ELITechGroup Inc. - June 27, 2025

ELITEchGroup MDX LLC, a manufacturer in Bothell, WA, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA) and for receiving, reviewing, and evaluating complaints. These issues indicate significant deficiencies in the firm's quality system documentation and adherence to its own procedures.