FDA 483 - ContainMed, Inc. - February 19, 2020

ContainMed, Inc., a contract manufacturer in Indianapolis, IN, was inspected from February 12-19, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning the control of nonconforming product, rework procedures, and the maintenance of device history records. These issues indicate a lack of adequate documentation and established procedures for critical manufacturing and quality control processes.