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Merck KGaA, Serono division

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Company: Merck KGaA, Serono division
Plants: Fenil-sur-Corsier, Switzerland; Aubonne, Switzerland; Rome
Warning letter: Dec. 15, 2011

Each of the three Merck KGaA plants in the Merck Serono division was cited for the kinds of things that might be noted at any plant. They include changes in process at Corsier-sur-Vevey in Fenil-sur-Corsier, Switzerland, that were not documented and reported; a lack of written procedures on mitigating contamination risks at the Aubonne plant; and the failure to thoroughly investigate batch failures noted at the Rome plant. What sets this warning letter apart from most is that it appears that the FDA was checking the German company's manufacturing capabilities along its supply chain. It inspected the three plants over a four-week period. The Corsier-sur-Vevey plant manufactures APIs, the Aubonne plant finished drug products and the plant in Rome inspects drugs bound for the U.S.

The agency has acknowledged the need to step up inspections of foreign plants. It has received some additional money in the FDA user fee reauthorization. In testimony to Congress this year, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, pointed out that there are now more foreign drugmakers than U.S. drugmakers for it to inspect. While the agency is trying a number of programs to stay on top of that growth, the Merck 3-in-1 approach may serve as an indication of what it has in mind.

And the demand that it made of Merck may also serve as a blueprint for other companies. The "FDA expects Merck KGaA to undertake a comprehensive and global assessment of your manufacturing operations in all your facilities to ensure global, adequate, and timely resolution of the issues, including making needed improvements to your quality system."