FDA 483 - Vayuclear Inc - March 14, 2025

Vayuclear Inc, a specification developer in Mount Pleasant, SC, was inspected by the FDA from March 10-14, 2025. The inspection revealed 11 significant deficiencies primarily related to design control, device history records, labeling, supplier management, and quality system procedures for their Class II medical device, the Vortex - Surgical Suction Clearing System. The firm failed to adequately document design validation, output, and plans, maintain accessible device history records, and establish proper procedures for suppliers, CAPA, and finished device acceptance.