Ezar AI, Inc.January 28, 2025

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

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Record Details

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.

Company: Ezar AI, Inc.
Inspection Date: January 28, 2025
Product Type: Device
Office: New York District Office
Person: Kwong P. Lee (investigator)

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