Eyenovia, Inc.April 5, 2023

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

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Record Details

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.

Company: Eyenovia, Inc.
Inspection Date: April 5, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
People: Michael Araneta (issuing_officer)
Bryan A. Galvez (Pharmaceutical investigator)

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ID · 4e00ab80-e15b-48fa-8a28-6ad107f6175e