Abbott Laboratories, maker of FreeStyle glucose monitors has received a warning letter from the Food & Drug Administration noting numerous manufacturing violations at its Alameda, California plant, according to a recent article in the Wall Street Journal.
According to the FDA, the company didn’t follow quality control procedures and didn’t correct problems it identified properly, such as scratches found on FreeStyle Lite blood sugar testing strips. Furthermore, the company said it found key personnel at the company were not qualified for their posts.
The company said it has taken steps to correct the problems and is communicating its actions with the FDA.
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