FDA 483 - Veridiam, Inc. - October 10, 2024

Veridiam, Inc. in El Cajon, CA, was cited on a Form FDA 483 following an inspection from October 7-10, 2024. The inspection revealed significant deficiencies in the firm's complaint handling procedures, which were deemed inadequate. Specifically, the firm failed to properly define complaint sources, include requirements for evaluating and investigating device failures, and document investigation statuses for multiple complaints.