TrueCare Biomedix Cited for Slew of Procedural Problems
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.