date:May 12, 2012
cause the dietary supplements manufactured in your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice requirements for dietary supplements.
The company sent a written response to FDA in October 2011 to the FDA-483 presented at the conclusion of the inspection. How