FDA 483 - Boston Brace International Inc - June 29, 2023

Boston Brace International Inc, a medical device manufacturer in Avon, MA, was inspected by the FDA and received a Form 483 with nine observations, including repeat findings. The inspection revealed significant deficiencies across multiple quality system areas, particularly concerning CAPA, complaint handling, nonconforming product control, documentation, equipment maintenance, management review, quality audits, and employee training. These issues indicate a systemic lack of adequate procedures and record-keeping for ensuring product quality and regulatory compliance.