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

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.