FDA 483 - BBS Enterprises, DBA Complexus Medical - February 04, 2026

An FDA inspection of BBS Enterprises in Mishawaka, IN, from February 2-4, 2026, revealed significant deficiencies in their quality management system. Observations included a lack of validation for production processes, inadequate documentation of product requirements for intended use, and a failure to apply a risk-based approach to corrective actions and overall risk management in product realization. These issues indicate systemic problems in ensuring product quality and safety.