FDA Enforcement
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
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…
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,…
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…
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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