Vanda Pharmaceuticals IncMarch 12, 2024

FDA 483 - Vanda Pharmaceuticals Inc - March 12, 2024

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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.

Company: Vanda Pharmaceuticals Inc
Inspection Date: March 12, 2024
Product Type: Drugs
Office: Office of Regulatory Affairs
People: Brittany L. Carpenter (investigator)
David L. Chon (Consumer Safety Officer/BIMO Investigator)

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ID · 43444eed-9c8f-4ef6-98fe-0ea3af1fae29