FDA 483 - Biedermann Motech, Inc. - November 23, 2022

An FDA inspection conducted at Biedermann Motech, Inc., a medical device specification developer in Miami, FL, from November 22-23, 2022, identified two key observations related to their quality management system. The first observation indicated that procedures for controlling nonconforming product were not adequately established or implemented. For instance, a Nonconforming Report (NCR 2021-020) opened in October 2021, detailing the use of incorrect raw material steel by a contract manufacturer, remained unresolved with no documented evidence of supplier notification, investigation, or corrective actions nearly a year later. The second observation revealed that the firm's complaint handling system was not adequately followed. Specifically, several complaint records, including 2022-001, 2022-003, 2022-007, and 2022-008, lacked the required second-person review for their assessment, investigation, and conclusion, as mandated by the company's own procedures. These observations, issued under the regulatory framework of the Federal Food, Drug and Cosmetic Act, necessitate Biedermann Motech, Inc. to address the identified issues by developing and implementing comprehensive corrective actions and providing a formal response to the FDA. The firm is also responsible for internal audits to ensure full compliance with quality system requirements.