FDA 483 - Embolx, Inc. - January 19, 2023

Embolx, Inc. in Sunnyvale, CA, a specification developer, received a Form 483 with six observations primarily concerning deficiencies in their quality system. Key issues include inadequate medical device reporting procedures, incomplete complaint investigation records, insufficient CAPA documentation and effectiveness checks, and failures in management review, quality audits, and supplier evaluation processes. The observations indicate systemic issues in maintaining an effective quality system.