Genzyme's Allston Landing Facility in Massachusetts, one of the world's largest cell culture manufacturing plants, has become the focus of an enhanced enforcement action in what is perhaps a sign of an increasingly tough stance at the US Food and Drug Administration (FDA) on manufacturing standards. The action, announced in March, has led to a draft consent decree from FDA that requires Genzyme to pay a $175 million “up-front disgorgement of past profits,” the company said. If the Allston plant continues to miss deadlines for domestic and exported products, the draft also calls for a 18.5% disgorgement of revenues from products produced and distributed from the plant, and it could include heavy fines ($15,000 per day per violation) if overall cGMP compliance is not met in coming years. The 185,000-square-foot Allston facility produces Genzyme's therapeutic enzymes for rare genetic diseases—products that bring in more than one-third of Genzyme's $4.5 billion in annual revenues. A February 2009 warning letter from the FDA and several '483 citations' (formal notices to a manufacturer of a violation) have documented problems at the plant that impact product quality and show a lack of written procedures, training, system maintenance and environmental testing. Genzyme, based in Cambridge, Massachusetts, has responded to the latest FDA action by bringing in The Quantic Group, a Livingston, New Jersey–based quality consulting firm, and moving its fill and finish operations to Hospira, a contract service company in Lake Forest, Illinois. In February, it also hired Scott Canute, formerly of Indianapolis, Indiana–based Eli Lilly, as president of global manufacturing and corporate operations. This followed the recruitment in January of Ron Branning—formerly with Gilead Sciences of Foster City, California—as senior vice president of global product quality. Until two years ago, FDA personnel had regularly inspected the Genzyme facility and had no complaints. It was only after a new inspector began to tour the facility that things changed. “It was like night and day,” says a person familiar with the situation, who spoke to Nature Biotechnology on condition of anonymity. “Initially, the company didn't know what to think or how to respond.” Genzyme's response took too long and fell short of the FDA's expectations. The FDA's move toward greater oversight and more stringent adherence to GMP is possibly the result of criticisms levied following the heparin contamination debacle (Nat. Biotechnol. 26, 589, 2008) and other food and drug safety problems. In the 2010 budget, the agency received an increase of more than a half-billion dollars, up to $3.2 billion, with an emphasis on improving product safety.