FDA 483 - Globe Scientific LLC - October 11, 2022

Globe Scientific LLC, a repackager/relabeler in Mahwah, NJ, received a Form FDA 483 with seven observations during an inspection from October 4-11, 2022. The observations primarily highlight significant deficiencies in their quality system, including a lack of established procedures for corrective and preventive actions, nonconforming product control, device history records, and medical device reporting. The firm also failed to adequately investigate customer complaints and appoint a management representative for quality system oversight.