GlobalMed Inc. – FDA 483, Apr 27, 2023

GlobalMed Inc., a medical device contract manufacturer in Trenton, received a Form FDA 483 with four observations during an inspection from April 24-27, 2023. The inspection identified deficiencies in process validation, corrective and preventive action procedures, incoming product acceptance, and equipment maintenance schedules. These issues indicate a need for improved quality system controls at the facility.