The Food and Drug Administration (FDA) warned Abbott Laboratories’ (ABT) diabetes unit about manufacturing violations involving the company’s blood-glucose-monitoring systems, according to a report published on NASDAQ.com.
The July 2 letter stemmed from a March inspection of an Abbott Diabetes Care Inc. facility in Alameda, Calif., that makes the FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems. The devices are used by people with diabetes to monitor their blood-glucose, or blood-sugar levels. The letter was posted to FDA’s website Tuesday.
The FDA said the company failed to follow proper quality-control testing and inspection procedures when correcting problems such as scratches found on some FreeStyle Lite monitoring strips.