FDA 483 - GPI USA, Inc. - August 25, 2023

GPI USA, Inc., a software manufacturer in Houston, TX, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically lacking a risk-based approach for impact assessment in their CAPA process. Additionally, procedures for design verification were not adequately established, as an unimplemented work instruction was used for verification testing of their e-Delphyn Donor Software, leading to test failures.