FDA 483 - Medical Accessories and Cables LLC - August 26, 2019

Medical Accessories and Cables LLC, a specification developer of medical device cables in Houston, TX, was cited for significant deficiencies during an FDA inspection. The firm failed to establish procedures for receiving, reviewing, and evaluating complaints, leading to undocumented investigations of defective devices. Additionally, the company lacked developed, maintained, and implemented written Medical Device Reporting (MDR) procedures, failing to ensure timely and accurate reporting of adverse events.