Among the violations cited in a recent FDA warning letter to Abbott Diabetes Care is one concerning the qualifications of operations personnel. The violation is described as "failure to have sufficient personnel with the necessary education, background, training and experience," to ensure that product quality meets regulatory requirements.
It's a noteworthy case, in which the regulator is comparing the educational background and professional experience of employees against that specified by the company in its description of their jobs, says Jim Prutow, director at consultancy PRTM's healthcare practice, in an interview.
For example, the FDA cites the company for employing a quality systems director who has a business administration degree, rather than the Bachelor of Science in a technical or engineering discipline that's specified in the job description. Similarly, the company's "regulatory affairs manager lacks the minimum of five years of regulatory experience required in the job description."
Likewise with the quality control supervisor and calibration coordinator, who each come up short compared with stated job requirements.
- see the warning letter