The Food & Drug Administration warned Abbott’s (NYSE:ABT) diabetes care division after discovering problems at an Alameda, Calif., plant that makes glucose monitoring products.
In a July 2 letter, the federal watchdog said inspections revealed problems with the plant’s quality control and inspection processes. The plant makes Abbott’s FreeStyle glucose monitoring and Navigator continuous monitoring systems.
Citing incidents in which empty blister packs and scratched FreeStyle Lite glucose test strips were produced, the FDA said the company failed "to verify or validate the corrective and preventative action to ensure that such action is effective and does not adversely affect the finished device," according to the letter.
The agency also cited Abbott for failing "to have sufficient personnel with the necessary education, background, training, and experience" to meet FDA regulations:
"For example:
- The job description for the Director of Quality Systems requires that the person have a Bachelor of Science/Technical/or Engineering discipline. The person holding the position does not have this type of degree, but rather a Business Administration degree.
- The person holding the Regulatory Affairs Manager position lacks the minimum of 5 years of regulatory experience required in the job description.
- The person holding the Quality Control Supervisor position lacks the required Bachelor degree in science or the alternative five to eight years experience in Quality Control.
- The person holding the Calibration Coordinator position lacks the required Bachelor degree and the four years of relevant experience.”
Abbott has 15 working days from the date of the letter to address the issues it raises. If the issues are not corrected, the FDA can take “regulatory action” without further notice.