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

Source: https://www.keypedia.com/records/483/eyenovia-inc/4e00ab80-e15b-48fa-8a28-6ad107f6175e

> FDA 483 for Eyenovia, Inc. on April 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eyenovia, Inc.
- Inspection Date: 2023-04-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/eyenovia-inc/75c9d00c-0669-4e69-84cb-77cbc9a53660

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b