483 of the week: lying QC manager edition
The Form 483 relays an especially troubling event during the inspection when Sichuan Deebio’s quality control team leader provided “misleading information” about records on the results of a microbiology test.At first, the quality control chief lied about viewing those test results, logging them and leaving them with another team member on a different floor of the facility, the FDA contends in its report. Then she changed tack, claiming she had not read the results, before switching back to a story similar to her first. At last, the QC chief “finally” admitted that she was “not telling the truth about recording the results on respective data worksheets, and no worksheet existed,” investigators wrote in the Form 483.To make matters worse, investigators subsequently asked the quality leader how she kept track of the test results, to which she replied that they were “in her ‘mind.’”
There's a lot of lab results in my mind (well, there was), but I usually tried to write them down really quickly.