FDA 483 - Stickman Dialysis Industries, LLC - August 08, 2019

Stickman Dialysis Industries, LLC in Arundel, ME, was inspected, revealing significant deficiencies in its quality system. The firm lacked adequate procedures for equipment calibration, device history records, medical device reporting, quality audits, and management reviews. These observations indicate a broad failure to establish and implement essential controls for regulatory compliance and product quality.