FDA 483 - Exxonmobil Product Solutions Company - December 11, 2025

Exxon mobil Product Solutions Company in Baton Rouge, LA, received a Form 483 following an inspection of its API manufacturing facility. The inspection revealed significant deficiencies in the firm's quality unit responsibilities, including inadequate change control, insufficient investigations into stability failures, and improper stability study practices. Additionally, the firm's cGMP training was found to be inadequate for pharmaceutical API manufacturing.