FDA 483 - Nortec Quimica SA - July 22, 2022

Nortec Quimica S.A., an API manufacturer in Duque de Caxias, Brazil, was cited for significant deficiencies during an FDA inspection. Observations included failures in quality unit oversight, lack of stability data for exported APIs, uncontrolled analytical records, and critical data integrity issues with computerized systems lacking proper access controls and backup procedures. These findings indicate a lack of robust quality control and data management practices.