FDA 483 - CardioQuip, LLC - September 17, 2021

An FDA inspection of CardioQuip, LLC in College Station, TX, revealed significant deficiencies across multiple quality system areas for their MCH-1000 medical devices. The firm failed to adequately establish procedures for design changes, design validation, and risk analysis, particularly concerning microbial contamination and aerosolization risks. Furthermore, the company demonstrated inadequate complaint handling, medical device reporting (MDR) procedures, and corrective and preventive action (CAPA) documentation, leading to uninvestigated complaints and misclassified reportable events.