GMP Issues Cited in Warning to Abbott Diabetes Care

Abbott Diabetes Care has received a warning letter about GMP violations at its Alameda, Calif., facility, which makes FreeStyle and Navigator blood glucose monitoring products. FDA investigators noted that the sampling of three lots for quality control testing and inspection was out of compliance, according to the letter. The company also failed to address problems with empty blister packs and scratches on its FreeStyle Lite strips. Abbott is taking actions to address the concerns, spokesman Greg Miley said.
The GMP Letter