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 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)

Focused on helping manufacturers, distributors, and importers quickly resolve FDA audits and respond to 483s and Warning Letters.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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