Darmstadt/Höhn, May 2015
In April, the U.S. Food and Drug Administration (FDA) carried out a four-day audit at Mechatronic AG’s production site in Höhn/Westerwald.
The routine inspection of the company, which develops and produces medical technology devices on behalf of its customers, serves to monitor compliance with Current Good Manufacturing Practice (CGMP) regulations (21 Code of Federal Regulations Part 820). During the course of the audit, the U.S. authorities not only inspected the production site, but also reviewed to what degree Mechatronic AG’s internal processes and procedures and its implemented quality management programme comply with FDA regulations regarding the development and production of medical devices. Mechatronic AG passed the audit without any deviations and is thus “FDA accepted”.