FDA 483 - Dechoker, LLC - February 26, 2021

DeChoker LLC, a medical device manufacturer in Wheat Ridge, CO, received an FDA Form 483 citing significant deficiencies in its quality system. The firm failed to submit a Medical Device Report for a serious injury, lacked adequate design controls and process validation, and exhibited systemic issues across various quality system elements including risk analysis, change control, management review, CAPA, acceptance activities, process controls, rework procedures, and quality audits. These findings indicate a broad failure to establish and implement a compliant quality system for medical device manufacturing.