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, the 483 said, but there was no information in the complaint records to support how the determination was made. Seven of nine complaint records related to an infusion pump or ventilator battery holding a charge, but the firm did not identify this as a trend in its CAPA reports.
There was no evidence of risk assessment activities being performed nor was there evidence to support re-training of personnel as part of CAPA procedures, the agency said.
The firm’s process control procedures were found to be inadequate because lot numbers and expiration dates were not recorded as part of the manufacturing record, and there was no value recorded for the number of samples tested to meet specifications. Acceptance criteria were also found lacking in that the product acceptance status didn’t indicate whether a product conformed to specifications.