FDA EIR - ISP Sutton Laboratories - September 01, 2011

An FDA surveillance inspection of ISP Chemicals LLC, an active pharmaceutical ingredient (API) manufacturer in Chatham, NJ, was conducted from August 31 to September 1, 2011. This inspection, guided by Compliance Program 7356.002F for API processes, covered Quality, Production, and Laboratory Control Systems. Key observations highlighted several areas for improvement. The firm lacked appropriate controls on computerized systems, specifically regarding user access privileges allowing data modification/deletion, and backup procedures for electronic laboratory data. Additionally, raw materials, such as urea, were not consistently weighed during manufacturing. The inspection also identified issues with uncontrolled laboratory worksheets, insufficient documentation of instruments used in analyses, and the absence of clear sample preparatory procedures for standards. Finally, there was no written procedure defining the Quality Unit’s responsibilities. Despite these findings, an FDA Form 483 was not issued. Management committed to implementing voluntary corrections, including securing electronic records, establishing backup and user access procedures, ensuring all raw materials are properly weighed, controlling laboratory documentation, and developing a comprehensive Quality Unit procedure.