FDA 483 - Clean Solutions LLC - May 10, 2024

Clean Solutions LLC, an OTC manufacturer in Clifton, NJ, was inspected by the FDA from May 6-10, 2024. The inspection revealed significant deficiencies across multiple areas of its manufacturing operations, including a complete lack of quality control, inadequate testing of raw materials and finished products, and unvalidated processes and equipment. These serious violations indicate a systemic failure to adhere to CGMP requirements for the production of Antibacterial Hand Soap.