FDA 483 - TriReme Medical, LLC. - June 17, 2022

An FDA inspection of Trireme Medical, LLC. in Pleasanton, CA, revealed significant deficiencies in quality control and record-keeping for their medical devices and drug products. The firm failed to adequately control non-conforming products, maintain device master records, ensure data integrity for computer systems, and properly store drug products under controlled temperature conditions. These issues suggest a need for comprehensive improvements in their quality management system.