The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India.
The agency found that the drugmaker had multiple written procedures that were inadequate. For instance, a procedure for sampling in-process, finished products shipped to the U.S. did not include specific details to ensure representative samples were taken, such as where to collect in-process samples and how to obtain representative in-process samples.
In addition, the firm’s complaint handling procedure did not include directions to extend complaint investigations to other products potentially affected, and the firm’s vendor approval and qualification procedure did not confirm the reliability of the manufacturer’s certificate of analysis.
The investigator also found the firm’s laboratory records unreliable. For example, it failed to document all high-performance liquid chromatography data and activity in its quality control laboratory, and analysts in the QC laboratory were able to change date and time settings on all standalone workstations in addition to sharing the same username and password.
Equipment used in the QC laboratory was also not properly calibrated. Since January 2014, the firm’s polystyrene film used to calibrate Fourier-transform infrared spectroscopy devices was not calibrated. In addition, weights used for checks on analytical balances were found to have scratch and indentation marks that could impact test accuracy.
Equipment was also improperly maintained, including water lines on the humidifiers of the firm’s stability study chambers. Written procedures were not established to describe how to clean them and cleaning them was not a part of the firm’s preventative maintenance plan. Water drain lines on the stability study chambers were also not affixed to the drain pipe in order to prevent water leaking around the chambers.
In addition, the firm did not document or quantify evidence of deterioration for certain products as part of its annual inspection. It also failed to follow its cleaning procedure for a manufacturing and packaging area, and the investigator found drug product residue after the room was labeled clean.