FDA 483 - GreenMark Biomedical Inc. - April 18, 2025

An FDA inspection of GreenMark Biomedical Inc. in Ann Arbor, MI, a manufacturer of medical devices, revealed significant deficiencies across its quality system. The firm failed to document supplier evaluations, adequately monitor production processes, and maintain records for incoming product acceptance. Additionally, management reviews were not conducted, Unique Device Identifiers were not uploaded to the GUDID database, and raw data for equipment operational qualifications were unavailable.