FDA 483 - JSM SOLUTIONS LLC - January 10, 2024

JSM SOLUTIONS LLC in Faribault, MN, was inspected and cited for significant deficiencies in its quality system. The firm was found to be manufacturing and distributing Class 1 and 2 medical devices without an established quality system, documented design inputs, or approved suppliers and consultants. These issues indicate a fundamental lack of control over critical aspects of medical device production and quality assurance.