FDA Enforcement
Regulatory Mediator
Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions,…
FSMA Inspections
FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for…
What represents an FDA Consent Decree?
An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice…
SNAP Trafficking Charge Letter
Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS (United States Department of…
FDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
FDA Enforcement and Recall Report Week of July 18
FDA Recalls Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the…
FDA Enforcement and Recall Report Week of July 11
FDA Recalls Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the…