FDA 483 - Vitae Enim Vitae Scientific, Inc. - September 22, 2021

Vitae Enim Vitae Scientific, Inc. in San Diego, CA, was inspected and cited for significant deficiencies across its quality control, production, facility, equipment, and laboratory operations. The inspection revealed a systemic lack of written procedures and adherence to established controls, particularly concerning change control, aseptic processing, environmental monitoring, and product release testing. These issues indicate a severe lack of control over drug product quality and sterility assurance.