FDA 483 - Zuga Medical Inc. - April 12, 2022

Zuga Medical Inc. in Chagrin Falls, OH, a medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately control its contract manufacturers, establish robust CAPA and design control procedures, maintain proper complaint files, and conduct required risk analyses, quality audits, and management reviews. These issues indicate a systemic breakdown in ensuring the quality and safety of its Class II dental implants.