Biowave Corporation – FDA 483, Jun 21, 2023

Biowave Corporation, a medical device manufacturer in Norwalk, CT, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in its quality system, including inadequate procedures for complaint handling and supplier qualification. Additionally, the inspection revealed a complete lack of internal quality audits and management reviews, indicating systemic failures in maintaining an effective quality system.