With over 30 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is representation of drug compounders, both in the FDCA Section 503A and 503B spaces. She handles matters related to FDA and state board inspections, Form 483 and Warning Letter including CGMP and USP remediation activities, investigations, regulatory meetings, board hearings, and consent decree negotiations.

Ms. Palmer also has significant expertise in DEA and FDA enforcement and litigation matters including but not limited to administrative proceedings. She advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a broad spectrum of compliance and regulatory issues including administrative proceedings at DEA involving, but not limited to, registrant revocation actions, including the appeal of those matters in federal courts throughout the country.