FDA 483 - Omega Medical Imaging, Inc. - August 26, 2022

Omega Medical Imaging, Inc. in Sanford, FL, was inspected regarding its manufacturing processes for medical devices. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for corrective and preventive actions and the control of nonconforming products. These issues indicate a failure to properly address and document product discrepancies and prevent their recurrence.