FDA EIR - Integrated Commercialization Solutions LLC - July 15, 2019

An FDA inspection of Integrated Commercialization Solutions LLC, a drug and component repacker and labeler located in Brooks, KY, was conducted from July 11-15, 2019. The inspection, carried out under current Good Manufacturing Practice (cGMP) regulations for drug products, identified two significant areas requiring attention. Firstly, the company lacked a robust qualification process for employees performing visual inspections of finished products. This included an absence of established procedures for preventing visual fatigue, conducting eye examinations, providing test kits for defect identification, and maintaining standardized inspection stations. Furthermore, there were no defined acceptance criteria for batches based on visual inspection results, nor documentation identifying inspecting personnel in batch records. This indicates a gap in ensuring product quality and safety during critical visual checks. Secondly, the inspection found a failure to thoroughly investigate discrepancies and customer complaints, specifically regarding corrective actions. Approximately 58% of non-conformance cases from 2017-2019, totaling around 260, were attributed to 'procedure not followed' errors, yet the firm’s policy did not mandate corrective action unless a low performance threshold was met. Additionally, the Quality Unit failed to ensure timely completion of investigations, with deviations, customer complaints, and corrective and preventive actions (CAPAs) remaining open for extended periods, some exceeding 700 days. The company was issued inspectional observations (FDA-483), requiring them to develop and implement appropriate qualification programs for visual inspectors, establish clear acceptance criteria, improve documentation, and develop effective, timely corrective and preventive action processes to address identified issues and prevent recurrence.