Posts by Marc Sanchez
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 to medical device (and food) firms (distributors/manufacturers/importers etc.). The FDA released the top 10 medical device observations at a recent Regulatory Affairs Professional Society breakfast. The top 10 observations for…
Read MoreTop 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, which can result in a Warning Letter. Upon request the Atlanta Regional Office’s Director of Compliance provided Food Court the top observations made in food. They are: 21 CFR 110.35(c)…
Read MoreBREAKING 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 its history, breaking its all-time record for the third consecutive year. That averages out to a new 483 every 52 minutes! Marc C. Sanchez – Contract In-House Counsel and Consultant(sanchezmarc.com)…
Read MoreFatty Foods Addictive Like Cocaine – What Would a Fatty Food Suit Look Like?
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Read MoreMobile Medical Apps (From Food Court foodct.com)
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Read MoreChina 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 link to the full post. n January, the Food Safety Modernization Act (FSMA) was passed and signed into law in the United States. This Act is the first overhaul…
Read MoreFood 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 set of recall requirements companies must follow. There are three components to the new recall requirements: mandatory recalls, FDA consumer-friendly recall website , grocery store notices to shoppers. The FDA
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