Christopher A. Fanelli
Christopher (Chris) Fanelli, a former FDA enforcement lawyer, works with pharmaceutical and biotechnology firms to come up with practical solutions to thorny FDA compliance and enforcement issues. Chris uses his FDA know-how to assist pharmaceutical and biotechnology firms, large and small, in responding to FDA 483s, Warning Letters, Import Alerts, and other FDA enforcement actions.
Chris also helps clients prepare for FDA inspections, provides support during FDA inspections, and routinely counsels clients on GMP and data integrity requirements, product labeling, import issues, product recalls, and other compliance matters.
Prior to joining Hogan Lovells, Chris worked in the FDA's Office of the Chief Counsel, where he was an Associate Chief Counsel for Enforcement. Chris prepared and brought numerous FDA enforcement actions, and personally negotiated many consent decrees on behalf of the agency.
Assist a large drug manufacturer in responding to FDA Warning Letter.
Assist several large drug companies in responding to FDA 483s.