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Published on 21 July 2010

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Abbott warned by FDA on factory

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Pharmaceutical giant Abbott Laboratories has received a warning from the US Food and Drug Administration (FDA) about manufacturing problems at a plant in California.

Officials from the FDA carried out an inspection at the Alameda facility and found that the firm’s Freestyle and Navigator blood glucose monitoring products were adulterated and not conforming with codes for good quality system manufacturing practices.

The report also claimed that the company had failed to address the manufacture of empty blister packs and scratches on FreeStyle Lite test strips. The diabetes care unit was also cited as failing to establish and maintain adequate procedures for validating device design.

Company spokesman Greg Miley said: “The letter relates to our corrective and preventative measures and some of our internal validation and documentation procedures. Abbott Diabetes Care has taken and continues to take actions necessary to address the items outlined in the letter, and is communicating those actions directly to the agency.”

Mr Miley added that the availability of the products were not affected.

The FDA warned that Abbott Laboratories could face further regulatory action if it did not act on the report.

Copyright Press Association 2010

FDA



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