FDA 483 - Opus KSD, Inc. - November 12, 2021

Opus KSD, Inc. in Pembroke, MA, was inspected from November 10-12, 2021, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's procedures for complaint handling and adverse event reporting, as well as inadequacies in their design input procedures. These issues indicate a need for improved quality system controls.