On December 31, 2015, the FDA issued the Zhejiang Hisun Pharmaceutical Company a warning letter that highlighted issues with good documentation practices, including the following observations:

“During the inspection, we reviewed the electronic log for high performance liquid chromatography (HPLC) system #36 and determined that the audit trail was disabled on February 6, 2014. One of your analysts executed 80 HPLC injections for assay and impurity tests of validation stability batches….”

The FDA goes on to explain that:

“Because the audit trail was disabled, neither your quality unit nor your laboratory staff could demonstrate that records for these batches included complete and unaltered data. All supporting raw data was discarded, including sample solution dilutions and balance weight printouts. Sample analyses were not recorded in the instrument use logbook. Test results were deleted from the hard drive and all supporting chromatograms were discarded. Audit trail functions were re-enabled on February 8, 2014, and the same analyses were repeated. You submitted the February 8th test results to the FDA in March 2014 in support of Drug Master File…”

The warning letter continues with further explanation that:

“During the inspection, we asked the analyst who generated the data submitted to the FDA whether audit trails could be disabled. The analyst stated that another employee, who was no longer with the company, had disabled the audit trails. Your firm could not explain why the audit trail was disabled or why the original data was deleted, nor could you demonstrate whether the original results were within specification.”