FDA EIR - Exxonmobil Product Solutions Company - March 09, 2018

An FDA surveillance inspection was conducted at Exxon Mobil Chemical Company in Baton Rouge, LA, from March 5-9, 2018. The company is registered as a drug manufacturer, producing non-sterile Isopropyl Alcohol (IPA), including a USP grade Active Pharmaceutical Ingredient (API). The inspection focused on the firm's quality system, facilities, equipment, laboratory, materials, production, and packaging/labeling systems for IPA manufacturing, under regulatory frameworks for API and animal drug inspections (C.P. 7356.002F, CP 7371.001). The inspection resulted in an FDA Form 483, highlighting three main observations. Firstly, the company failed to ensure the API met quality and purity specifications. This included releasing multiple IPA conveyances with out-of-specification (OOS) appearance results, some without complete release testing, and one conveyance shipped before receiving passing test results. Secondly, Exxon Mobil failed to adequately investigate and document OOS results, such as numerous appearance failures in conveyances, and did not implement appropriate corrective actions. Lastly, the quality unit did not perform an annual product review for the IPA API, which should encompass failed batches, non-conformances, stability monitoring, complaints, recalls, and corrective action adequacy. Management, represented by Technical Division Manager Brian W. Jones, acknowledged the observations and committed to a written response within 15 business days. The FDA emphasized the necessity of full compliance to applicable regulations, warning of potential regulatory actions if corrective measures are not implemented.