FDA 483 - Vivant Skin Care, LLC - December 05, 2024

Vivant Skin Care, LLC, an OTC drug manufacturer in Miami Lakes, FL, was inspected by the FDA from December 2-5, 2024. The inspection revealed significant deficiencies across equipment qualification, facility contamination prevention, quality control unit procedures, and product testing. These issues indicate a lack of adherence to current Good Manufacturing Practices (cGMP) for OTC drug production.