FDA EIR - Exxonmobil Product Solutions Company - December 11, 2019

An FDA surveillance inspection of Exxonmobil Chemical Company's bulk drug manufacturing facility in Baton Rouge, LA, was conducted from December 9-11, 2019. This inspection followed the regulatory framework for animal drug manufacturing. The primary focus was to assess the company's operations, including facilities, equipment, materials, production, and laboratory controls, and verify corrective actions from a previous inspection (March 2018). During the prior inspection, Exxonmobil received observations concerning failures to maintain Standard Operating Procedures for Active Pharmaceutical Ingredient (API) quality, investigate out-of-specification results, and conduct annual product reviews. The current inspection confirmed that the company had implemented the necessary corrections to address these previous objectionable conditions. Notably, the December 2019 inspection did not result in the issuance of an FDA-483 form for new inspectional observations. However, one questionable practice was discussed with management: a contracted company responsible for loading and sampling ExxonMobil's products lacked documented evidence of its required employee training. Management committed to addressing this training documentation issue. This positive outcome indicates the company's diligence in resolving past deficiencies and maintaining compliance within the Good Manufacturing Practice guidelines, with a minor area identified for further procedural clarity.