FDA EIR - Exxonmobil Product Solutions Company - March 21, 2013

An FDA surveillance inspection of Exxon Mobil Chemical Company's Baton Rouge, LA facility was conducted from March 19-21, 2013, focusing on their manufacturing of Isopropyl Alcohol (IPA), a critical Active Pharmaceutical Ingredient (API). The inspection, performed under the Drug Process Inspections regulatory framework, identified significant issues primarily concerning product quality and safety controls. The main violation highlighted was the lack of documented validation for the company's computerized system, particularly its alarm functions for monitoring critical impurities like Benzene. The firm was unable to provide approved and signed evidence of successful acceptance testing for this vital analyzer/computer alarm interface. Management committed to an extensive search for existing validation records and, if unsuccessful, to conduct a retrospective validation of the system. Additionally, concerns arose regarding the interpretation of endotoxin test results for process water, where observed values appeared inconsistent with expectations, requiring further clarification. Discrepancies in the Certificate of Analysis for finished IPA were also noted, specifically regarding the reporting of Specific Gravity and Water Miscibility according to global specifications. The FDA emphasized the company's responsibility to comply with all applicable requirements of the FD&C Act.