FDA 483 - Medco Manufacturing - September 07, 2023

Medco Manufacturing, a medical device manufacturer in Spring, TX, was inspected by the FDA and received a Form 483 with seven observations, many of which were repeat findings. The inspection revealed significant deficiencies across multiple quality system areas, including design change, finished device acceptance, corrective and preventive actions, device history records, servicing procedures, quality audits, and management review. These issues indicate a systemic failure to maintain an effective quality system for their Class II MEDCO Aspirator IV portable aspiration pump.