MatOrtho Ltd – FDA 483, Mar 5, 2020

An FDA inspection of MatOrtho Ltd, a medical device manufacturer in Leatherhead, United Kingdom, revealed seven significant deficiencies in their quality system. The firm failed to adequately manage complaints, validate design changes, verify labeling accuracy, and establish proper procedures for finished device acceptance, corrective actions, and nonconforming product control. These observations indicate a need for improved adherence to regulatory requirements to ensure device quality and safety.