FDA 483 - OcuMetrics, Inc. - December 12, 2019

GenMetrics, Inc. in Mountain View, CA, was inspected by the FDA, resulting in four observations primarily concerning deficiencies in their quality system. The inspection revealed significant issues with corrective and preventive actions (CAPA) procedures and documentation, including repeat observations from previous inspections. Additionally, the firm lacked adequate control over suppliers and had not established proper procedures for changes to existing procedures.