Nortec Quimica SA – FDA EIR, Jul 22, 2022

A routine surveillance inspection of Nortec Quimica SA, an Active Pharmaceutical Ingredient (API) manufacturer in Duque de Caxias, Brazil, was conducted by the FDA from July 18 to July 22, 2022. This inspection adhered to CP 7356.002F for API Process Inspection and ICH Q7 Good Manufacturing Practices for APIs. The inspection resulted in three significant observations detailed in an FDA Form 483. Key issues included the improper delegation of the independent quality unit's responsibilities, specifically regarding the review of batch production records and ensuring stability data for product expiry. Additionally, the company's computerized systems lacked adequate controls to prevent unauthorized data access or changes, prevent data omissions, and comprehensively record all data alterations. Finally, there was an identified absence of robust backup systems and data protection measures to safeguard against permanent record loss from system failures. Nortec Quimica SA management agreed to implement corrective actions for all observations. Consequently, the FDA inspector recommended an "Official Action Indicated (OAI)" classification, indicating that further regulatory action may be necessary due to serious concerns regarding the company's compliance with pharmaceutical manufacturing standards.