FDA 483 - MAXOGEN GROUP LLC - June 05, 2023

MAXOGEN GROUP LLC, a specification developer in Hollywood, FL, received a Form FDA 483 with 10 observations during an inspection. The firm demonstrated significant deficiencies across its quality system, including failures to implement procedures for CAPA, complaint handling, design control, device records, non-conforming products, MDRs, supplier management, management reviews, and internal audits. These issues indicate a fundamental lack of a functional quality system for its Class II medical device, Bite Helper.