FDA 483 - Prizm Medical, Inc. - October 25, 2021

Prizm Medical, Inc. in Buford, GA, a medical device manufacturer, was inspected by the FDA from October 18-25, 2021. The inspection revealed significant issues with the documentation of acceptance activities for incoming, in-process, and complaint-related testing. Additionally, the firm failed to adequately implement procedures for controlling nonconforming products, including failed circuit boards and customer complaints.