FDA 483 - CPAC Equipment, Inc. - June 09, 2025

An FDA inspection of CPAC Equipment, Inc. in Leicester, NY, a medical device manufacturer, revealed significant deficiencies across its quality system. Observations included a lack of documented software validation, inadequate control of nonconforming products, insufficient complaint handling, and missing quality audits and management reviews. The firm also failed to document incoming product acceptance, design reviews, and personnel training, indicating broad systemic issues.