FDA 483 - Ezar AI, Inc. - January 28, 2025

Ezar AI, Inc., a medical device manufacturer in New York, NY, was cited for two observations during an FDA inspection. The firm failed to develop written Medical Device Reporting (MDR) procedures and lacked an Electronic Submissions Gateway (ESG) account for eMDR. Additionally, the documentation for document approvals was found to be inadequate, specifically regarding individual signatures and dates.