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Website claims and GMP violations continue to dominate FDA warning letters
date:May 12, 2012
03(a)(1) of the Act [21 U.S.C. 343(a)(1)) because FDA does not certify compliance with the dietary supplement current good manufacturing practices under 21 CFR Part 111.


Actions speak louder than words


Florida-based SEI Pharmaceuticals, Inc. received a warning letter following an inspection of the companys dietary supplement manufacturing facility in September 2011.


The agencys inspectors reported violations of FDA's Current Good Manufacturing Practice (CGMP) regulations. These violations

08/02 20:08