FDA EIR - BASF Corporation - September 11, 2024

An unannounced, routine FDA surveillance inspection of BASF Corporation's facility in Bishop, Texas, an active pharmaceutical ingredient (API) manufacturer specializing in Ibuprofen API, was conducted from September 9 to September 11, 2024. This inspection, part of the FY24 Drug Inspection work plan, focused on Good Manufacturing Practices (GMP) for non-sterile API produced by chemical synthesis. It followed Compliance Program 7356.002F and utilized ICH Q7 as guidance for regulatory compliance. The inspection did not result in the issuance of an FDA 483-Inspectional Observation. However, one verbal observation was communicated to management: the presence of white residue on the floor of the packaging room after it had been mopped. This suggested the cleaning solution was not fully removing API residue. The company's management acknowledged the observation and informed the inspector that they were already actively working to identify and implement a more effective cleaning solution for the area. No specific formal regulatory actions were mandated by the FDA as a result of this inspection. The inspector emphasized the firm's ongoing responsibility to ensure all operations comply with current applicable laws and regulations.