US FDA Warning to Shanghai Desano Chemical Pharmaceutical Co. China

Failure to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards.

Your laboratory personnel conducted “unofficial” testing without appropriate documentation, justification, and investigation.

The original, unofficial analyses were stored in a separate “Test” folder and were not part of the official quality control records. Our inspection found that your firm performed circa 8,400 of these unofficial chromatographic analyses between 2012 and 2014. According to your SOP-B-QC-022-01, Instrument Use Standard Operating Procedure, analysis of samples must be documented. The volume of data in these auxiliary “Test Folders” suggests that performing unofficial analyses is a common practice at your facility.

Your quality unit must review all pertinent analytical data when making batch release decisions in order to determine batch quality. During the inspection, a member of your staff told our investigator that you were now in the process of reviewing these unofficial analyses.

Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded.
Your firm failed to investigate and document a number of production deviations. During the inspection, our investigator found many electronic logs of production deviations in a folder titled “GMP Anomalies.” Our investigator randomly selected folder 01/2014 from your electronic log, compared it to your firm’s official deviation logbook for 2014, and found that the deviations in the “GMP Anomalies” folder were not investigated or reported in the official deviation logbook.