FDA 483 - Morgan Newton Comp. - February 11, 2020

Morgan Newton Company, a medical device manufacturer in Plano, TX, was inspected by the FDA and cited for multiple quality system deficiencies. The inspection revealed a lack of documented procedures for production, incomplete documentation of acceptance test results, and inadequate control over product acceptance status and document changes. Additionally, the firm failed to validate equipment, properly implement corrective and preventive action procedures, and document maintenance activities, indicating significant gaps in their quality management system.