FDA 483 - Peripheral Visions, Inc. - January 27, 2020

Peripheral Visions, Inc. in Black Diamond, WA, a manufacturer of Class II electrodes, was inspected by the FDA from January 21-27, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established procedures for complaint handling, CAPA, nonconforming product, quality audits, process control, design control, device history records, purchasing control, document control, and training. Several observations were repeats, indicating a systemic failure to implement basic quality system requirements.