FDA Enforcement

Criminal Charges USPlabs LLC

Criminal Charges USPlabs LLC Breaking News – Criminal Charges USPlabs LLC  The US Department of Justice and the Food and Drug Administration announced criminal charges and…

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New FDA Automatic Destruction Rule

New FDA Automatic Destruction Rule Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015)….

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FDA Criminal Liability – PCA and the DOJ Yates’ Memo

Peanut Corporation of America executives Stewart Parnell and Michael Parnell were sentenced yesterday following a conviction last year for their role in the salmonella outbreak linked…

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FDA Warning for Kim Kardashian

FDA Warning for Kim Kardashian A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian…

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Nutrient Content Claims + KIND Warning Letter

Nutrient Content Claims + Kind Warning Letter What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of…

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FDA Warning Letters

FDA Warning Letters The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters…

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FDA Regulatory Status Call

FDA Regulatory Status Call Managing Engagement with the US FDA to Avoid Penalties One of the most challenging aspects of working with the FDA is…

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GNC to Strengthen Supplement Quality Controls – Implications for Suppliers

The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the…

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Review: FY 2014 Inspectional Observation Summaries

At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…

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FTC Sues Gerber Over Unapproved Health Claim

The US Federal Trade Commission announced today its intent to sue Gerber for unapproved and unsubstantiated health claims made on its

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Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ

An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…

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Data Integrity and Form 483 or Warning Letters

Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.

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