483
Sanit Technologies, LLC dba DurisanFDA 483 - Sanit Technologies, LLC dba Durisan - May 17, 2019
Record Details
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.
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · b83eab5c-a210-468d-a731-65001332edd2