WARNING

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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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 Auhtority; Second Suspension Under New FSMA Powers

The US Food and Drug Administration (US FDA) suspended the food facility registration of Roos Foods of Kenton, Delaware. The facility registration is required by…

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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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