FDA 483 - Seriously Clean, Ltd. - March 11, 2026

Seriously Clean, Ltd. in Nixa, MO, a manufacturer of Nixall Wound and Skin Solution, was cited for multiple deficiencies during an FDA inspection. The firm failed to calibrate critical measuring equipment, did not include unique device identifiers (UDI) on product labels, and inadequately maintained supplier evaluation records. These observations indicate a lack of control over manufacturing processes and supplier management.