FDA 483 - Raptor Pharmaceuticals Inc. - August 24, 2016

Raptor Pharmaceuticals Inc., a drug manufacturer in Novato, CA, was inspected and cited for two significant issues. The firm failed to report twenty-seven serious and unexpected adverse drug experiences for its product PROCYSBI to the FDA within the required 15 calendar days. Additionally, their procedures for handling drug product complaints were found deficient, particularly concerning adverse events reported via social media and the lack of complaint trending.