FDA Enforcement

Update: Supreme Court overturns Calif. Law on Euthanizing Downed Livestock (National Meat Association v. Harris (10-224))

Food Court reported in

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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling

Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the

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Top 10 Device Observations in 2011 (Citations made in Form 483s)

The FDA increased the number of inspections in 2011 to a record level. This resulted in a new level of Form 483 Inspectional Observations issued…

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Top Food Observations in 2011 (Citations made in Form 483s)

Yesterday Food Court reported on the top ten observations made during a facility audit. Observations are the citations made in a Form 483 Insectional Observation,…

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BREAKING NEWS – FDA Breaks All-Time Record, Issuing 10,000 483s

There are reports that the FDA will surpass 10,000 483s (the citation given before a formal warning letter) in 2011 for the second time in…

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Food Court: Food Safety Modernization Act – Prodcut Recall Manual

There are many important features for the food industry in the new Food Safety Modernization Act. The focus of this post is on the new…

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