The U.S. Food and Drug Administration recently sent a warning letter out to Abbott Diabetes Care Inc., an Alameda, Calif.-based company that manufactures glucose-monitoring equipment.
(Tip o’ the hat to Jim Edwards who first wrote about it here.)
Among the varied charges leveled in the letter is that the company did not conform to necessary guidelines when hiring for critical positions at the company, especially ones that are responsible for quality control, calibration of equipment and regulatory affairs:
4. Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by 21 CFR 820 are correctly performed, as required by 21 CFR 820.25(a). For example:
a. 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.
b. The person holding the Regulatory Affairs Manager position lacks the minimum of 5 years of regulatory experience required in the job description.
c. 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.
d. The person holding the Calibration Coordinator position lacks the required Bachelor degree and the four years of relevant experience.
We have reviewed your response dated March 26, 2010, and have concluded that it is not adequate because the replacement Regulatory Affairs Manager does not have qualifications that meet the qualifications required in the job description. You stated that you are conducting a global review of personnel to compare qualifications and job descriptions of all individuals who have direct product impact to determine if their background and experience match the requirements of their current job description and are conducting a review of the Human Resources processes that support the development of job descriptions and the identification and selection of personnel. However, this process is ongoing and evidence of its completion and effectiveness was not provided.
For its part, the company says it is working with the FDA to clear up the problems.
“Abbott Diabetes Care has taken and continues to take the actions necessary to address the items outlined in the letter and is communicating those actions directly to the agency,” says Greg Miley, the company’s director of public affairs.
But with all the highly skilled — yet unemployed –workers out there currently flooding the job market, it boggles the mind to think that the company’s HR department is not able to find any qualified candidates for such important positions.
Furthermore, if you are an end-user of one of Abbott’s products, such as the FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems, how sure are you that the product in your hand has been properly calibrated and tested for quality assurance if the people responsible for such things may not be qualified to do their jobs?
When critical positions are filled by unqualified candidates, it’s a simply a recipe for disaster.