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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
EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination
New changes are emerging from the French scandal involving breast implants. The European Commission (EC) will investigate whether or not to recommend
USDA Seeks Comments on Revisions to Food Container Standards
The USDA us propsing changes to the Standards for Condition of Food Containers (Title 7 Part 42), which sets out the standards for defects and…
OMB Says Food Agency Merger Is Next
In its Friday edition, The Hagstrom Report said Office of Management and Budget Director for Management, Jeff Zients, said that if Congress grants Obama 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…
China Law Blog Guest Post – United States Food Safety Reaching To China
I published a guest post on a colleague, Dan Harris’ blog – China Law Blog. An excerpt of the post is included below with a…