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Lapses at big drug factories add to shortages and danger

The New York Times, October 19, 2012
Recent quality lapses at big drug companies show that contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis. In the last three years, six of the major manufacturers of sterile injectable drugs—which are subject to rigorous inspections by the federal government, as opposed to compounding pharmacies, which are generally overseen by the states—have been warned by the Food and Drug Administration about serious violations of manufacturing rules. Four of them have closed factories or significantly slowed production to fix the problems. Nearly a third of the industry's manufacturing capacity is off line because of quality issues, according to a Congressional report.