Holland Company, Inc. - April 17, 2009

USP active pharmaceutical ingredient drug products are manufactures and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of the ACT as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports to possess.