Phrase: "Failure to have sufficient personnel"
From: Unnumbered warning letter dated July 2, 2010, to Abbott Diabetes Care
In this ordinary-looking warning, which includes three counts of validation shortcomings, the FDA takes the unusual step of comparing the educational background and professional experience of Abbott operations employees against those specified by the company in its description of their jobs. 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.
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."
It's noteworthy, says Jim Prutow, director at consultancy PRTM's healthcare practice, who notes several instances of what he describes as "questionable" warning letter observations. "Personnel might have extensive experience in the field," says Prutow, "which might be the reason for overlooking their lack of the specified degree."
Prutow's analysis of questionable observations