# Elevar Therapeutics, Inc. – FDA 483, May 20, 2026

Source: https://www.keypedia.com/records/483/elevar-therapeutics-inc/05cec2bf-312f-460c-be43-b9600ad1bbe1

> FDA 483 for Elevar Therapeutics, Inc. on May 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elevar Therapeutics, Inc.
- Inspection Date: 2026-05-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Elevar Therapeutics, Inc. in Fort Lee, NJ, was issued a Form FDA 483 following an inspection that identified a significant deficiency in their oversight of a clinical trial. The firm failed to ensure a study was conducted in accordance with its Monitoring Plan, specifically by not promptly addressing an investigator's non-compliance. This included a sustained refusal of ophthalmic facility access and inadequate resolution of deficiencies, without initiating formal corrective actions commensurate with the severity of the issues.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/elevar-therapeutics-inc/f71beff4-164c-4514-bfe8-73d4e3d32173

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248