FDA 483 - CMP Pharma Inc - December 21, 2016

CMP Pharma Inc, a drug manufacturer in Farmville, NC, received a Form 483 with two observations concerning its post-marketing adverse drug experience (ADE) reporting. The firm failed to report individual ADEs to the FDA in 15-day alerts and include them in periodic safety reports, and its written procedures for handling post-marketing ADEs were found to be inadequate. These deficiencies highlight significant issues in the firm's pharmacovigilance system.