Hyman Phelps and McNamara
We offer many years of experience helping clients both avoid and respond to FDA enforcement activities. Specifically, we have provided advice and representation in:
  • FDA, DEA and State Inspections

  • Current Good Manufacturing Practices and Quality System Regulation

  • Responding to FDA Form 483s

  • Responding to Warning Letters

  • Handling recalls, and working with FDA on recalls

  • Responding to product seizures by FDA

  • Defending against injunctions sought by FDA

  • Responding to FDA requests for Consent Decrees, and negotiating and complying with Consent Decrees

  • Negotiating with FDA to prevent or remove client listings under FDA's Application Integrity Policy

  • Responding to DEA administrative show cause orders

  • Civil penalty hearings

  • Criminal investigations and prosecutions

  • Import/export detentions

  • Responding to grand jury, civil, administrative, and criminal subpoenas
HPM frequently represents clients in matters originated by the FDA, DEA, CPSC, DOJ, the Federal Trade Commission (FTC), and various state agencies. We defend manufacturers against federal and state False Claims Act actions involving alleged violations of the Federal Food, Drug, and Cosmetic Act, federal health care programs, anti-kickback laws, and other laws.

Primary Contacts:


Paul Hyman

Robert Dormer

Diane McColl

A. Wes Siegner, Jr.


Paul Hyman

Robert Dormer

Anne Walsh

Internal Investigations

Douglas Farquhar

Robert Dormer

Karla Palmer

Clinical Trials/GCP compliance/IRB issues

David Clissold


Douglas Farquhar

James Ellison

Karla Palmer

Anne Walsh

Ricardo Carvajal

John Gilbert, Jr.

Larry Houck

Kurt Karst

Riette van Laack

Jeffrey Gibbs

Firm Publications