Genzyme, FDA finalize Consent Decree

Genzyme Corp. (NASDAQ:GENZ) finalized and signed FDA's Consent Decree regarding deficiencies at the company's Allston, Mass., manufacturing plant. As expected, Genzyme is required to pay a $175 million fine and move fill/finish operations out of the plant by Nov. 28 for U.S. products and Aug. 31, 2011, for ex-U.S. products. Missing either deadline would incur a further penalty of 18.5% of revenues on any products filled/finished at the plant after the deadlines. Genzyme also is required to draft and implement a remediation plan, which it said will require 2-3 years to complete (See BioCentury Extra, Wednesday, April 21, 2010). ...