FDA 483 - Allied Medical LLC - May 20, 2022

Allied Healthcare Products Inc received a Form 483 citing significant deficiencies across its quality system, particularly concerning nonconforming product control, corrective and preventive actions, and design changes for its portable ventilators. The inspection revealed issues with complaint handling, MDR reporting, device history records, risk analysis, and environmental controls, indicating a broad lack of adherence to established procedures and regulatory requirements. These findings suggest a high potential for product quality issues and patient safety risks.