FDA 483 - Sanit Technologies, LLC dba Durisan - May 17, 2019

Durisan, an OTC drug product manufacturer in Sarasota, FL, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked a functional quality control unit, proper batch records, adequate laboratory controls with established specifications, and essential procedures for water system sampling, equipment cleaning, and employee training. These issues indicate a severe lack of control over manufacturing processes and product quality.