Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland United States, a new study suggests.

Researchers found that drugs produced at plants located in Puerto Rico that are owned and operated by U.S. pharmaceutical firms were more likely to have quality problems than those produced by the same firm in a matched plant on the U.S. mainland.

The results show how difficult it is to transfer world-class quality control to an offshore plant, even under the best of conditions, says John Gray, lead author of the study and assistant professor of operations at Ohio State University’s Fisher College of Business.

“Many people, including some pharmaceutical executives, think offshore plants can produce drugs at significantly less cost but with the same quality risk as plants in the United States,” says Gray. “But we found that may not always be the case.”

“We believe the quality differences we found in Puerto Rico plants were driven by challenges in transferring knowledge from headquarters to the plant, due to cultural differences, primarily differences in language and values.”

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