FDA ramps up GMP inspections
This article was originally published in The Tan Sheet
Executive Summary
FDA plans to increase its inspections of supplement firms' compliance with good manufacturing practices as the June compliance date approaches for small companies, those with up to 20 employees. Stephen Sundlof, Center for Food Safety and Applied Nutrition director, said other "pressing needs for inspections," such as salmonella-tainted peanut products, have had the agency's attention. However, CFSAN "will be going back and looking at the compliance of the industry with GMPs now that they are mandatory," he said at the Food and Drug Law Institute's annual conference April 22. FDA's June 2007 supplement GMP final 1rule required firms with 500 or more employees to be in compliance a year later and those with more than 20 employees by June 2009 (2"The Tan Sheet" May 11, 2009)