FDA 483 - Mark Berman, M.D. - December 05, 2019

An FDA inspection of Mark H. Berman, M.D., a medical device manufacturer in Beverly Hills, revealed significant deficiencies in its quality system for breast implantation devices. The firm failed to establish numerous critical procedures, including design controls, supplier evaluation, process controls, sterilization validation, acceptance activities, nonconforming product control, CAPA, complaint handling, device history records, device master records, storage controls, MDRs, management review, quality audits, and personnel training. These failures indicate a comprehensive lack of a robust quality system, potentially impacting the safety and efficacy of devices implanted in patients.