FDA 483 - Aero-Med LLC - October 26, 2023

An FDA inspection of Aero-Med LLC, a medical device establishment, was conducted from October 18 to October 26, 2023. The inspection identified two main observations indicating deficiencies in the company's quality management system. First, the firm did not have established procedures to ensure that all purchased or received products and services conform to specified requirements. Specifically, a critical component used in blood collection card manufacturing was received from unapproved vendors, without proper receiving documentation, incoming quality control inspection, or verification of required storage conditions. Second, Aero-Med LLC lacked established procedures for controlling environmental conditions. This was observed in the storage of the same component, which requires specific temperature and expiration controls but lacked adequate inventory management and environmental monitoring. These findings suggest a need for improved adherence to the regulatory framework governing medical device quality systems. Aero-Med LLC is expected to undertake internal self-audits to identify and correct all quality system violations and submit a formal response detailing their corrective actions to the FDA.