FDA 483 - Whitney Products Inc. - August 22, 2019

Whitney Products Inc., a medical device manufacturer in Niles, IL, was inspected and cited for three observations related to its quality system. The inspection revealed deficiencies in the firm's control and disposition of nonconforming products, inadequate documentation and implementation of corrective and preventive actions, and failures in establishing equipment maintenance schedules. These issues indicate a need for improved adherence to established procedures and regulatory requirements.