FDA 483 - Medco Manufacturing - May 13, 2019

Medco Manufacturing, a medical device manufacturer in Spring, TX, was inspected and cited for severe deficiencies across its quality system. The firm failed to maintain device master records, device history records, and lacked established procedures for acceptance activities, complaint handling, and medical device reporting. Many quality system procedures were found to be merely forms and not implemented, indicating a fundamental lack of a functional quality system for their MEDCO Aspirator IV device.