FDA 483 - Lifesignals Inc - May 21, 2025

Lifesignals Inc. in Milpitas, CA, a specification developer, was cited for two observations related to its quality system. The firm's medical device reporting (MDR) procedure was found inadequate for timely event identification and evaluation, potentially leading to incorrect reportability decisions. Additionally, complaint handling procedures were not adequately established, specifically regarding investigation documentation and review of quality records.