Baxter Hit With FDA Warning Over Puerto Rico Plants

Law360, New York (January 27, 2011, 7:03 PM EST) -- The U.S. Food and Drug Administration has sent an official warning to pharmaceutical company Baxter Healthcare Corp. over practices at two manufacturing plants in Puerto Rico, alleging breaches of manufacturing regulations and a failure to submit post-marketing reports.

Baxter said in a statement Thursday that it had received a warning letter from the FDA's district office in San Juan following routine inspections at Baxter's Guayama and Jayuya facilities, where Baxter manufactures certain nutrition and critical care products and an anesthesia agent.

The FDA alleged the Deerfield,...
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