FDA EIR - BASF Corporation - April 18, 2019

An FDA inspection of BASF Corporation's active pharmaceutical ingredient (API) Ibuprofen manufacturing facility in Bishop, TX, took place from April 16-18, 2019. Conducted under the regulatory framework for pharmaceutical manufacturing, the inspection evaluated quality, raw materials, production, and equipment validation. No FDA-483 (Inspectional Observations) form was issued, indicating an absence of significant deficiencies. Despite no formal observations, discussions during the close-out highlighted three areas of concern. First, the computerized monitoring system for Ibuprofen API production had not been re-validated since its 1992 installation, with a related supplementary device lacking re-validation since 1998. Second, changing production packaging procedures lacked formal monitoring via a CAPA. Third, there was inadequate control over contracted personnel involved in packaging and labeling, which was linked to elevated weight deviations in the annual product review. BASF management acknowledged these conditions and presented planned corrective actions. These included a major project to upgrade and validate the computerized monitoring system by October 2021. To address issues with contracted labor and packaging deviations, the firm intends to implement an additional layer of supervision, ensuring closer monitoring and oversight of packaging and labeling personnel.