FDA 483 - GEO Specialty Chemicals, Inc. - October 10, 2024

GEO Specialty Chemicals, Inc. in Deer Park, TX, an API manufacturer, was cited with three observations during an FDA inspection. The firm failed to establish an effective quality management system, evidenced by recurring foreign object contamination despite corrective actions. Significant issues were also noted in laboratory controls, including data integrity concerns with HPLC and FTIR instruments, lack of audit trail review, and inadequate electronic data backup. Additionally, the firm lacked proper quality agreements with third-party laboratories for microbial testing.