Baxter’s PR operations get FDA warning letter

Written by  //  January 27, 2011  //  Manufacturing  //  No comments

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The operations of yet another local pharmaceutical company are in the Food & Drug Administration’s cross-hairs, receiving a warning letter from the agency over violations to good manufacturing practice requirements, the Wall Street Journal reported Thursday.

As of late afternoon, the FDA had yet to post copies of the warning letter it sent to Baxter International Inc. regarding the findings at two of its local plants dedicated to making nutritional and critical-care products. Baxter has plants in Aibonito, Guayama and Jayuya.

Late in the day, a Baxter spokeswoman told the Associated Press that the letter points out manufacturing practices violations at the Jayuya facility and the failure by the Guayama plant to file post-market surveillance reports.

Baxter’s local troubles became public earlier this week, when CEO Robert Parkinson Jr. admitted to the existence of the letter during a conference call to announce quarterly results, when he also said the company had addressed the issues the FDA brought up. The letter, coupled with a double-digit decline in fourth quarter and 2010 profits sent Baxter’s stock plunging.

Baxter reported $423 million in fourth quarter net income, reflecting a 26 percent decline from the $572 million reported in the same prior-year period. For the full year, Baxter reported net income of $1.4 billion, a 36 percent drop compared to net income of $2.2 billion reported for the same 12-month period in 2009.

Although the warning letter was absent from the FDA’s site, in a separate action documented in December, the agency disclosed that Baxter’s Aibonito plant had recalled more than 752,000 units of sterile injection manifold devices intended for use with vascular access blood sampling units and the administration of multiple drugs and solutions. The devices were recalled in the U.S. and Japan.

Baxter is the latest manufacturer to join a seemingly growing list of local plants facing production and quality issues. Johnson & Johnson’s McNeill plant in Las Piedras and Bristol-Myers Squibb in Manatí have also had run-ins with the FDA in recent months.

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