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news.The US Food and Drug Administration (FDA) has warned Abbott Laboratories (Abbott) over violation of current good manufacturing practice (CGMP) at a plant that makes in vitro diagnostic products for human use in Illinois.
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According to a warning letter dated August 12, 2009 and posted on November 17, 2009 on FDA’s Web site, FDA conducted an inspection at Abbott Molecular facility in Des Plaines, Illinois from June 2 to June 29, 2009. FDA investigators revealed that Abbott Molecular facility in Des Plaines lacked standard procedures for evaluating finished tests, preventing errors and controlling materials that didn’t meet specifications.
The FDA said it wants Abbott to notify the agency within fifteen (15) working days of August 12, 2009 of the specific steps taken to prevent violationsin the future.