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
- 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
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