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…

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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…

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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…

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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…

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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…

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FDA Consent Decree

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…

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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…

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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

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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…

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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…

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FDA Enforcement and Recall Report Week of July 4

  FDA Recalls – General Mills and Raw Cookie Dough Each week the FDA reports on its enforcement activities as a guide to FDA compliance….

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FDA Enforcement and Recall Report Week of June 27

Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty…

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