Biowave Corporation – FDA 483, May 26, 2026

An FDA inspection of Biowave Corporation in Westport, CT, revealed significant deficiencies across its manufacturing operations. The firm failed to provide adequate resources for its quality management system, exhibited inadequate incoming inspection procedures for its Biowave Home medical device, and did not timely submit a required Medical Device Report (MDR). These issues indicate a systemic lack of control over critical quality processes and regulatory compliance.