The FDA uncovered serious complaint handling and CAPA deficiencies during an inspection of Alpha Source’s Milwaukee, Wisconsin facility from Jan. 17 to Feb. 2 and handed the firm an eight-item Form 483 at the close of the inspection.
The manufacturer, which makes battery packs for medical devices including defibrillators, patient monitoring equipment and ventilators, failed to adequately investigate complaints of battery failures. For example, six of nine complaints were processed as alleging no failure of the device, labeling or packaging, although this was contrary to customer complaints that the devices failed.
All nine complaint records lacked adequate investigations that documented whether the device failed to meet specifications, whether the device was being used for treatment or diagnosis, the relationship of the device to reported complaints, and the root cause or corrective actions taken.
All of the complaints were evaluated as not being reportable, but there was no information in the complaint records to support how the determination was made.