FDA 483 - MANAMED INC. - May 21, 2024

MANAMED INC., a specification developer for Class II sequential compression devices in Denton, TX, was cited for significant deficiencies across its quality system. The inspection revealed failures in establishing and maintaining critical procedures for medical device reporting, corrective and preventive actions, supplier controls, design controls, and acceptance activities. Additionally, device master records and device history records were found to be inadequately maintained, indicating a systemic lack of control over product quality and regulatory compliance.