FDA 483 - Ceba-Tek, Inc. - February 17, 2023

An FDA inspection of Ceba-Tek, Inc., a dietary supplement contract manufacturer located in Melbourne, FL, was conducted from January 31 to February 17, 2023. The inspection resulted in seven observations documented on an FDA Form 483, indicating significant deviations from Current Good Manufacturing Practices for dietary supplements. A critical concern highlighted is that six of these observations are repeats from previous inspections spanning 2014 to 2021, demonstrating a persistent lack of adequate corrective actions. Key violations include the failure to establish identity, purity, strength, and composition specifications for components, and the absence of finished product specifications for potential contamination. The company also failed to qualify suppliers by verifying their certificates of analysis and did not maintain written master manufacturing records for each batch size. Furthermore, quality control lacked approved controls for automated mixing equipment, with no scientific rationale for processing ingredients of varying densities. Finally, equipment and utensils, including food contact surfaces, were observed drying outdoors and an insect was found on a capsule polishing brush, indicating improper cleaning and sanitization. Ceba-Tek, Inc. is now required to provide a detailed response outlining robust corrective and preventive actions to address these serious and long-standing deficiencies to ensure product quality and safety.