The Food and Drug Administration warned Abbott Laboratories about violation of quality-control requirement involving the company’s blood-glucose meters.

March inspection of an Abbott Diabetes Care Inc. facility in Alameda, Calif., found that the company failed to follow proper quality-control testing and inspection procedures on its FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems.

The devices are used by diabetic patients to monitor their blood-sugar levels.

In a letter dated July 2, FDA said that the unit also failed to correct problems when scratches were found on some FreeStyle Lite monitoring strips.

According to FDA officials, Abbott employees in key positions such as the regulatory affairs manager and the director of quality systems didn’t have the necessary “education, background, training, and experience” required under the job descriptions.

Company spokesman Greg Miley said: "The letter relates to our corrective and preventative measures and some of our internal validation and documentation procedures. Abbott Diabetes Care has taken and continues to take actions necessary to address the items outlined in the letter, and is communicating those actions directly to the agency."
FDA further warned that failure to promptly correct the violations may result in further regulatory action.