FDA Enforcement
FDA IHCTOA Letter
What does IHCTOA mean? FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert something may…
Redacting a FOIA Request
Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…
FDA Warning Letters 2017
FDA Warning Letters 2017 FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along…
Regulatory Mediator
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…
FSMA Inspections
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…
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…