Resources for Food and Drug Administration (FDA)

AP IMPACT: FDA Faults Drug Plants

www.chron.com

The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors. After the flecks were spotted again on the capsules, a blood-pressure medication called diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.

But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated _ or prevent future contamination, according to U.S. regulators.

Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.

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