# FDA 483 - Vanda Pharmaceuticals Inc - March 12, 2024

Source: https://www.keypedia.com/records/483/vanda-pharmaceuticals-inc/43444eed-9c8f-4ef6-98fe-0ea3af1fae29

> FDA 483 for Vanda Pharmaceuticals Inc on March 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vanda Pharmaceuticals Inc
- Inspection Date: 2024-03-12
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: 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.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)
- [investigator](https://www.keypedia.com/people/brittany-l-carpenter/600db4d0-0b6b-435f-b511-2ca10f292d5d)

Company: https://www.keypedia.com/companies/vanda-pharmaceuticals-inc/a60e506d-9654-41ce-a906-98706debec71

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64