Coral Springs, FL, April 21, 2009: Greystone Pharmaceutical Consulting, Inc., reported today that its President and Chief Pharmaceutical Consultant, Clifford Siporin, Ph.D. has observed that FDA has issued an unprecedented number of FDA enforcement actions due to alleged cGMP violations for both injectable and orally administered branded and generic drugs manufactured in both the US and ex-US locations. These allegations include those that can effect patient safety as product had been manufactured and distributed under these violative conditions such as superpotent tablets and solutions labeled for use in children.

Coupled with these allegations are further GMP violations including those related to validation of methods, keeping of records and marketing drugs without the benefit of an FDA approved NDA application as well as violations related to pharmacovigilance regulations and promotional claims. In certain of the most serious situations, FDA has sought and received Court ordered destruction of remaining drug stocks and issued recalls along with the closing of the manufacturing facility producing the adulterated products.

Companies that manufacture any drug products are urged contact Greystone (561 572 2700) to have an independent cGMP audit of their manufacturing facilities before FDA inspectors arrive to do the same. In this way, the potential violations can be addressed and corrected.

Companies being faced with such alleged egregious violations are seeking advice and help of Greystone to help outline a mitigation strategy for these violations that often include FDA-issued Warning and Regulatory letters.