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Medical Devices / Commercial Operations

Devicemakers in Puerto Rico Draw Ongoing FDA Attention

Dec. 8, 2017
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The FDA remains seriously concerned about shortages of certain medical products as manufacturers in Puerto Rico continue their slow recovery from Hurricane Maria, but the shortage of IV saline products should improve by the end of the year, Commissioner Scott Gottlieb said in his latest update.

The agency is working with Baxter to address the shortage of IV saline products by helping to stabilizing production in its Puerto Rican facilities, and it approved IV solution products manufactured by Fresenius Kabi and Laboratorios Grifols. 

It is also helping Baxter, one of the largest manufacturers of amino acids in the U.S. market, to temporarily import its amino acids for formulating IVs from its facilities in the United Kingdom and Italy, Gottlieb said. “Like with saline, an ongoing amino acid short supply situation was worsened by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities,” he said.

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