FDA 483 - Addivation Medical - January 12, 2023

Addivation Medical, a specification developer in Chester, NJ, was inspected regarding its sterile cervical interbody implant. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate validation of sterilization processes, lack of device master records, and insufficient control over design changes, supplier quality, and labeling. These issues indicate a systemic failure to maintain proper documentation and procedures for critical aspects of medical device manufacturing and quality assurance.