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