When British regulators suspended the license of Chiron's manufacturing plant in Liverpool, England, in October 2004, the move caught the US Food and Drug Administration by surprise and triggered an international vaccine crisis. The FDA had inspected the plant in the past, and Chiron was slated to provide nearly half of the US vaccine supply for 2004–2005: 48 million doses of Fluvirin. Instead, the United States scrambled to find enough vaccine to protect against influenza, which kills 36,000 Americans each year. The Emeryville, Calif.-based company's stock plunged, and it reported a $22.9 million net loss in the fourth quarter of 2004.
How could things go so wrong? When they closed the plant, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) cited bacterial contamination in some lots of vaccine, and a failure to follow good manufacturing practice. GMP is a set of regulations that are meant to ensure the safety, ...
