FDA 483 - Interscope, Inc. - May 05, 2023

Interscope, Inc. in Northbridge, MA, was inspected by the FDA from May 3-5, 2023. The inspection revealed a significant quality system deficiency related to the control of non-conforming medical devices. Specifically, the firm lacked adequate documented procedures for handling products that failed final acceptance testing, raising concerns about product mix-up and proper disposition.