Puerto Rican Drug Plants Shipped Tainted Pills: FDA

Quality control a problem at factories producing US' top-selling drugs

By Laurel Jorgensen, Newser Staff

Posted Feb 6, 2008 1:38 PM CST

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Puerto Rican Drug Plants Shipped Tainted Pills: FDA — A sign reads, in Spanish, "today we save lives," at the employee entrance to the factory operated by the pharmaceutical corporation GlaxoSmithKline PLC, or GSK, in Cidra, Puerto Rico, in this Oct. 31, 2007 file photo. The AP found that the Puerto Rican factories of several pharmaceutical companies,... (Associated Press)

The Caribbean island that produces 13 of the 20 best-selling drugs in the US has sold tainted pills and is struggling with quality control at its pharmaceutical plants, AP reports. FDA inspections of 13 Puerto Rican plants between 2003 and 2007 revealed problems such as machinery pins left in drug bottles and foreign material embedded in tablets.

Four of those plants have closed or plan to close, but none cited quality-control issues as the reason for shutting down. FDA officials largely attribute the problems to the island’s high number of pharmaceutical plants, saying the issue is generally no worse than an average US operation but because so many drugs are manufactured there, problems are magnified. Puerto Rico produces $35 billion of drugs every year and sells most of them in the US. (More Puerto Rico stories.)

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