ZIIP INC – FDA 483, Jan 12, 2026

ZIIP INC, a manufacturer of the ZIIP HALO device in Pleasant Hill, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate complaint handling, ineffective corrective and preventive actions, and failures in design control processes, including verification, validation, and change management. The firm also failed to adequately assess risks, submit required MDRs for serious malfunctions, and maintain a device master record.