FDA 483 - RR Donnelley - Supply Chain Solutions - September 29, 2023

An FDA inspection of RR Donnelley - Supply Chain Solutions in Plover, WI, revealed significant deficiencies in their quality system. The firm failed to adequately establish and document corrective and preventive action procedures, including issues with supplier validation and record completeness. Additionally, procedures for equipment maintenance were found to be inadequate, and management did not ensure the quality policy was understood by all employees.