FDA 483 - Morton Grove Pharmaceuticals, Inc. - March 26, 2014

During an inspection conducted from January 22, 2014, to March 26, 2014, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Morton Grove Pharmaceuticals, Inc. The inspection identified significant deviations from Current Good Manufacturing Practice (CGMP) regulations for human drug manufacturing. Key observations highlighted critical deficiencies in the company's quality control unit and laboratory operations. The firm's Quality Unit failed to adequately monitor quality systems, evidenced by the continued uncontrolled use of "trial" injections during chromatographic testing for drug release and stability, a practice previously cited in warning letters to other related facilities. Laboratory controls lacked scientifically sound procedures for these trial injections, which were not properly documented, reviewed, or subject to audit trails. Furthermore, raw data files could be deleted from computer systems by unauthorized personnel. Other notable issues included a failure to follow the stability testing program, incomplete investigations into out-of-specification results, and the quality unit's lack of authority to thoroughly investigate errors, such as recurrent product complaints regarding non-functioning spray actuators. Procedural changes were not adequately controlled, and production hold times were not appropriately established or tracked. Facility sanitation was also a concern, with mold observed in a hand dryer catch basin. Finally, deficiencies were noted in employee CGMP training and adherence to sanitation practices in manufacturing areas. Morton Grove Pharmaceuticals, Inc. is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations.