483
Clean Solutions LLCClean Solutions LLC – FDA 483, May 10, 2024
Record Details
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.
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ID · bad4c8f8-5594-4280-be6e-005fc3b846c5
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