Devicemaker Transfer Technology racked up a 12-item Form 483 covering a multitude of quality management issues following an FDA inspection of its Huntington Beach, California facility.
The maker of cardiac diagnostic supplies failed to validate production lots. Agency investigators noted that a validation document only contained two specifications. Both were handwritten with the word “pass” without providing identification of the validated lot, the quantity of the validated units, the validation date and the individual performing the validation, the investigator found.
The devicemaker also failed to provide documentation for design changes to certain electrodes, and impedance testing was only conducted for certain lots, even though all lots were signed as passing quality control.