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

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.