FDA 483 - Kapstone Manufacturing LLC - November 16, 2021

Kapstone Manufacturing LLC, a contract manufacturer in Charlotte, NC, was inspected by the FDA from November 8-16, 2021. The inspection revealed significant deficiencies across its quality system, including inadequate process validation, lack of control over nonconforming products, and insufficient procedures for labeling, CAPA, supplier management, and training. These issues indicate a systemic failure to adhere to established quality system regulations for medical devices.