JAC Custom Pouches, Inc. – FDA 483, Feb 1, 2023

JAC Custom Pouches, Inc. in Dowagiac, MI, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, control of nonconforming product, complaint investigations, training procedures, and device history records. These issues indicate a lack of robust quality management practices.