FDA 483 - Sanit Technologies, LLC dba Durisan - March 05, 2021

Sanit Technologies, LLC dba Durisan, an OTC drug manufacturer in Sarasota, FL, was cited for significant deficiencies in its quality control unit, manufacturing processes, and laboratory controls. The inspection revealed failures to investigate out-of-specification results, including microbial contamination in water and finished products, and a lack of proper validation for equipment and processes. Repeat observations from a previous inspection indicate persistent issues with CGMP compliance.