The FDA issued a Form 483 to HLPR saying the device contract manufacturer did not properly validate its processes or calibrate equipment.

The agency issued the form following a November/December 2017 inspection of the company’s Hamel, Minnesota facility. A process used for the company’s External Pulse Generator Disposable Pouch was not properly validated, according to the FDA, and a required test was not being performed.

The company also did not properly calibrate equipment used in the production of the disposable pouch, despite a provision in the company procedures stating that all equipment used for accepting product must be maintained and calibrated routinely and prior to use.

The facility lacked adequate device history records for the disposable pouch. The company also failed to maintain training records for at least two operators who assembled pouches in late 2014 and early 2015.