FDA 483 - Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. - September 20, 2024

During an inspection conducted from September 16-20, 2024, the FDA issued a Form 483 to Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc., a drug product manufacturer. The inspection revealed significant deviations from current Good Manufacturing Practice (cGMP) regulations. Key violations included inadequate written procedures for cleaning and maintenance of manufacturing equipment, specifically fluid bed dryers, which lacked sufficient detail to ensure visual cleanliness and prevent cross-contamination. Furthermore, equipment and utensils were not adequately maintained, with observations of a discolored hose, a cracked film coating panel, and a gauge with condensate. The facility itself showed signs of disrepair, including an opening in a ceiling, a hole in a wall with stagnant water, and a rusted water bath in the Quality Control laboratory. The laboratory control system was also found deficient, with expired sample and reference standard preparations being stored and, in some cases, used for critical dissolution testing, compromising data integrity. Finally, the firm's quality system had inadequate complaint records and investigations, specifically for product complaints regarding the "lack of effect" for Trulance, where investigations failed to include essential steps like testing retain samples or reviewing stability data. UPM Pharmaceuticals is required to submit a comprehensive response detailing corrective and preventive actions to address these observations and ensure regulatory compliance.