FDA 483 - Five Star Manufacturing, Inc. - August 29, 2025

Five Star Manufacturing, Inc. in New Bedford, MA, received a Form FDA 483 with three observations related to its quality system. The inspection revealed deficiencies in the corrective and preventive action (CAPA) process, inadequate control of nonconforming product storage, and a lack of established records for acceptable suppliers. These issues indicate significant gaps in the firm's quality management system.