FDA 483 - Zuga Medical Inc. - June 26, 2023

Zuga Medical Inc., a medical device manufacturer in Auborn Township, OH, was inspected by the FDA from June 12-26, 2023. The inspection revealed significant deficiencies in quality system procedures, including failures in complaint handling, acceptance activities documentation, quality audits, and design transfer processes. These issues indicate a lack of adequate controls for ensuring the quality and safety of their dental devices, particularly those sold in the Chinese market.