# FDA 483 - Validus Pharmaceuticals, Inc. - November 13, 2019

Source: https://www.keypedia.com/records/483/validus-pharmaceuticals-inc/e8e64a46-c633-4218-997c-0c88d5c8f829

> FDA 483 for Validus Pharmaceuticals, Inc. on November 13, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Validus Pharmaceuticals, Inc.
- Inspection Date: 2019-11-13
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Validus Pharmaceuticals, Inc. in Parsippany, NJ was inspected by the FDA from November 6-13, 2019, revealing significant deficiencies in postmarketing reporting. The firm failed to timely submit periodic adverse drug experience reports and annual reports for various applications. Additionally, the inspection noted a failure to include copies of published articles with postmarketing 15-day Alert reports based on scientific literature.

## Related Officers

- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/validus-pharmaceuticals-inc/4fc18f5f-2ae4-4655-8277-eb94af507596

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