FDA 483 - Koko, LLC - January 25, 2021

Koko, LLC, a medical device manufacturer in Longmont, CO, was inspected by the FDA from January 5-25, 2021. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process and software validation, design change controls, acceptance activities, complaint handling, risk analysis, and corrective and preventive actions. These issues indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.