WARNING

Nutrient Content Claims + KIND Warning Letter

What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of the KIND snack bar with a recent…

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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 are common food,…

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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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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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Nearly 25% of 2014 Warning Letters Issued to Seafood Industry

A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every…

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FDA Uses FSMA Suspension Authority; Second Suspension Under New FSMA Powers

The U.S. Food and Drug Administration (US FDA) suspended the registration of a food facility at Roos Foods in Kenton, Delaware. Facility registration is required…

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FY 2013 483 Data Released; Top Ten Observations Unchanged

The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…

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