FDA 483 - Vanda Pharmaceuticals Inc - March 12, 2024

Vanda Pharmaceuticals Inc. in Washington, DC, was issued a Form 483 following an inspection from March 4-12, 2024. The inspection revealed that the firm failed to notify the FDA of an investigator's termination from a study. Additionally, informed consent documents for a clinical study lacked disclosure of known allergic reaction risks to subjects, indicating deficiencies in sponsor oversight and subject protection.