FDA WARNING_LETTER - Nortec Quimica SA - July 22, 2022

The FDA inspected Nortec Quimica SA, a drug manufacturing facility in Brazil, from July 18-22, 2022, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). Consequently, the firm's API are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the failure to exercise sufficient controls over computerized systems, leading to unauthorized data access, changes, and omissions. Specifically, analysts could delete/overwrite data, over 100 deleted files were found, and stand-alone systems lacked unique user accounts, passwords, and backups. Additionally, the quality unit failed to adequately review batch production and laboratory control records prior to API distribution, neglecting complete raw data review from chromatography systems and lacking traceability controls for analytical worksheet forms. The FDA deemed the firm's responses inadequate, highlighting an overall lack of data integrity. The company is required to provide a comprehensive third-party assessment of computer system security, detailed plans for electronic data review and manual integration controls, a reanalysis plan for affected batches, and a global CAPA plan addressing data integrity lapses. A CGMP consultant is recommended. Failure to address these deviations may result in FDA withholding approvals and refusing admission of products into the U.S. A written response is required within 15 working days.