FDA EIR - BASF SE - July 13, 2018

A routine FDA surveillance inspection of BASF SE, located in Ludwigshafen Am Rhein, Germany, was conducted from July 9 to July 13, 2018. The inspection focused on good manufacturing practices (GMP) for non-sterile active pharmaceutical ingredients (API), guided by Compliance Program 7356.002F and ICH Q7 guidance. This review covered six key systems, including quality, facilities, materials, production, packaging, and laboratory controls.

The inspection concluded with the issuance of a three-item FDA Form 483, detailing observations of deficiencies. Key issues included the inadequacy of System Suitability for Test Method #PM00760, which lacked a precision Standard System Suitability (% RSD). Additionally, procedures for instrument calibration were found to be deficiently written or followed. Finally, the company lacked established control procedures to validate manufacturing processes that could impact variability in the packaging process.

Dr. Rainer Fendt, Global Quality Compliance Director, acknowledged these observations and committed to implementing corrective actions. BASF SE is required to submit a comprehensive response addressing these findings to the agency within 15 business days. The firm's drug manufacturer registration remains current.