FDA 483 - Eyenovia, Inc. - April 05, 2023

An FDA inspection of Eyenovia, Inc. in Reno, NV, a manufacturer and specification developer, revealed two significant observations. The firm failed to review and evaluate a validated process when changes or deviations occurred, specifically regarding ejector testing and retesting procedures. Additionally, the company lacked adequate procedures for verifying servicing activities of equipment, such as a dimensional analysis tool, before returning it to service.