FDA EIR - Exxonmobil Product Solutions Company - April 21, 2016

An FDA surveillance inspection of Exxon Mobil Chemical Company, located in Baton Rouge, LA, took place from April 19 to April 21, 2016. The inspection was conducted under C.P. 7356.002F, pertaining to Active Pharmaceutical Ingredient Process Inspections, as the company is registered as a drug manufacturer for Isopropyl Alcohol (IPA), including USP grade. The scope of the inspection covered the firm's Quality, Facilities/Equipment, Production, and Laboratory Systems related to IPA manufacturing. A key finding from a prior inspection in March 2013 involved a single observation documented on an FDA-483, concerning the validation of a computerized processing monitoring system. During this 2016 inspection, the FDA reviewed the company's updated validation records and supplementary information, confirming that the previous concern had been adequately addressed, with no major issues identified. Significantly, the current inspection concluded without any observations of non-compliance, and therefore, an FDA-483, List of Inspectional Observations, was not issued to Exxon Mobil Chemical Company. This indicates that the facility was operating in a compliant manner regarding its pharmaceutical manufacturing processes at the time of the inspection. Consequently, no specific regulatory violations were identified, and no corrective actions were required by the FDA.