FDA 483 - Prowess, Inc. - November 10, 2021

Prowess, Inc., a software manufacturer in Concord, CA, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action procedures, including inadequate investigations and unresolved issues with training and risk assessments. Additionally, the firm was cited for personnel lacking necessary training for their job functions and for failing to adequately document employee training.