Hyman Phelps and McNamara Hyman Phelps and McNamara
Enforcement
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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

  • 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:

Recalls

Paul Hyman

Robert Dormer

John Fleder

Diane McColl

A. Wes Siegner, Jr.

Roger Thies


Inspections

Roger Thies

Paul Hyman

Robert Dormer

John Fleder

Anne Walsh


Internal Investigations

Roger Thies

Douglas Farquhar

Robert Dormer

Karla Palmer


Clinical Trials/GCP compliance/IRB issues

Anne Marie Murphy

David Clissold


Litigation

John Fleder

Douglas Farquhar

James Ellison

Karla Palmer

Anne Walsh



Developments in the Law