FDA 483 - Biomat USA, Inc - September 13, 2023

An FDA inspection of Biomat USA, Inc., a Class II medical device manufacturer located in City of Industry, CA, took place from September 11-13, 2023. The inspection resulted in a Form FDA-483, identifying a key deficiency in the company's quality system. The primary observation was the absence of written Medical Device Reporting (MDR) procedures, a critical requirement for companies manufacturing medical devices. This means Biomat USA, Inc. lacked documented processes for reporting adverse events or product malfunctions to the FDA. Adherence to robust quality system requirements, including comprehensive MDR procedures, is essential for ensuring patient safety and compliance with federal regulations enforced under the Federal Food, Drug, and Cosmetic Act. The firm is responsible for developing and implementing these procedures to accurately track and report device-related issues. Biomat USA, Inc. has reportedly committed to correcting this observation, indicating their intention to establish the necessary written MDR procedures to meet regulatory standards and address the identified gap in their quality management system.