FDA 483 - Kobold, LLC - August 02, 2019

Kobold, LLC, a manufacturer of brachytherapy devices in Liberty Lake, WA, was cited for multiple deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for design review, design change, supplier evaluation and monitoring, document control, and labeling activities. These issues indicate a systemic lack of adherence to established quality processes and documentation requirements.