FDA 483 - Keystone Manufacturing LLC. - December 11, 2019

An FDA inspection of Keystone Manufacturing LLC. in Kalamazoo, MI, a medical device manufacturer, revealed five observations related to significant deficiencies in their quality system. The firm failed to adequately establish procedures for quality audits, corrective and preventive actions, nonconforming product control, and supplier controls. Notably, two observations were repeats from a previous inspection, highlighting persistent issues.