FDA warns Abbott on Texas plant

October 30, 2002

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The Food and Drug Administration has warned Abbott Laboratories that quality control at its drug plant in Austin, Texas, is lacking.

The warning letter, released on the agency's Web site Tuesday and dated Oct. 15, said Abbott failed to prevent rusty equipment from entering ''clean areas'' for manufacturing, fully investigate complaints of mold in injectable drugs, and test enough product samples to ensure quality.

The products made at the plant weren't named in the FDA's letter.

Abbott officials weren't immediately available for comment.

The FDA's findings resulted from an inspection in August. Abbott responded to the findings in three September letters and an October meeting with FDA officials. However, last week's letter said the agency found the company's plans for correcting the problems inadequate.

The FDA gave the North Chicago health care product maker the standard 15 working days to reply to the letter with a corrective action plan.

Earlier Tuesday, Abbott said it plans to build a $350 million manufacturing plant in Puerto Rico to make biologic products, including its experimental Humira treatment for rheumatoid arthritis.

Construction will begin immediately, Abbott said. The new plant will add 104 acres to Abbott's campus in Barceloneta, the company said.

AP, Bloomberg News