Abbott Laboratories (Abbott) has received a warning from the US regulators as it fails to follow good manufacturing practices (GMPs) standards at its Des Plaines facility, reported Daily Herald.
The FDA had conducted an inspection at Abbott Molecular facility in Des Plaines, Illinois from June 2 to June 29, 2009. After the inspection, the FDA’s investigators said that the facility is lagging behind in terms of the procedures for evaluating finished tests, preventing errors and controlling materials.
The FDA has also said that the facility is not meeting the good manufacturing practices standards.
However, the company said that it has already taken steps to resolve the problems. The plant manufactures molecular diagnostic tests.
Don Braakman, a spokesman for Abbott, said: “We’ve already taken a number of steps to address items outlined in the letter. We’re currently in the process of communicating those specific actions to FDA,” quoted the newspaper.