FDA 483 - 3D Medical Manufacturing, Inc. - June 23, 2023

An FDA inspection of 3D Medical Manufacturing, Inc. in Riviera Beach, FL, revealed deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's process for escalating nonconformances to CAPAs was found inadequate, particularly concerning risk determination for legacy parts without clearly identified critical to quality (CTQ) dimensions. This could result in product defects, as evidenced by a customer complaint about sharp edges on a part causing sutures to break during surgery.