FDA 483 - Vioguard, Inc. - January 17, 2019

Vioguard, Inc. in Bothell, WA, a specification developer for medical devices, was inspected by the FDA. The inspection revealed significant deficiencies across its quality management system, particularly concerning design control procedures for its UVKB50 keyboard, including design transfer, input, verification, and validation. Additionally, the firm lacked adequate procedures for risk analysis, contractor agreements, complaint handling, medical device reporting, CAPA, document control, quality audits, and management review, indicating a systemic failure to establish and implement essential quality system requirements.