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Baxter To Pay $15,000 Fine For Lax Testing

Drug and medical device maker agreed to pay a $15,000 fine for inadequately testing irradiation equipment at a plant in Puerto Rico.

WASHINGTON (AP) — Drug and medical device maker Baxter International has agreed to pay a $15,000 fine for inadequately testing irradiation equipment at a plant in Puerto Rico.
 
The Nuclear Regulatory Commission said Thursday its inspectors uncovered at least three violations during an inspection last March at a plant in Aibonito, Puerto Rico. In 2004, the commission fined Baxter $44,000 in 2004 for several violations at the same plant, including failure to follow safety procedures designed to protect workers from radiation exposure.
 
The March 2007 inspection showed the company did not conduct regular safety tests of irradiators used to kill germs that can form on medical products. The company also did not keep complete and accurate records of safety inspections and maintenance tests, the inspectors said.
 
''Deliberate acts'' by Baxter employees caused the problems, the inspectors concluded. A spokesman with Deerfield, Ill.-based Baxter said the employees responsible have been disciplined, but could not confirm whether they are still with the company.
 
In a settlement reached with the government in December, the company acknowledged the violations.
 
Thursday brought additional problems on the manufacturing front for Baxter. It recalled all vials of its blood thinner heparin, which was linked to deaths and allergic reactions. The company announced a partial recall earlier in the month.
 
Inspectors from the Food and Drug Administration are trying to determine whether a Chinese plant that makes the drug's key ingredient is the source of the problems.
 
While Baxter does not make drugs at the Puerto Rican plant, many U.S. companies do.
 
Thirteen of the 20 best-selling drugs in the United States come from plants in Puerto Rico. A recent 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.
 
Shares of Baxter International Inc. rose 3 cents Thursday to $59.96 in after-hours trading, following a close at $59.93.
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