Fred counsels firms and individuals on FDA regulatory compliance matters, including preparing for and responding to FDA regulatory inspections, Inspectional Observations and Warning Letters, and avoidance of civil and criminal enforcement actions. H also has extensive litigation experience with FDA enforcement actions, including administrative hearings, seizures, injunctions, and prosecutions.

Counseling Experience Includes:

• Preparing for and responding to regulatory inspections and violative observations.
• Developing and implementing corrective action plans.
• Internal corporate and due diligence investigations.
• Responding to Inspectional Observations and Warning Letters.

Litigation Experience Includes:

• Defending civil and criminal enforcement actions.
• Negotiating numerous consent decrees.
• Representing clients in Grand Jury investigations.