FDA 483 - PSM Medical Solutions - July 24, 2019

During an inspection, PSM Medical Solutions, a medical device manufacturer in Gunningen, Germany, was cited for failing to establish procedures for design validation. This deficiency was specifically noted in the design of their PSM BENEfit/quattro Screws, indicating a significant lapse in their product development quality system. The firm's own procedure defined design validation, but the necessary procedures were not implemented.