FDA 483 - Texas Eye Prosthetics, LLC - August 12, 2019

Texas Eye Prosthetics, LLC in Houston, TX, a medical device establishment, was inspected by the FDA from August 6-12, 2019. The inspection revealed five observations related to inadequate quality system procedures, including issues with CAPA documentation, labeling controls, device history records, equipment calibration, and control of nonconforming product. These observations indicate significant deficiencies in the firm's quality management system.