FDA EIR - BASF SE - March 17, 2010

An FDA inspection of BASF SE, an Active Pharmaceutical Ingredient (API) manufacturer located in Ludwigshafen Am Rhein, Germany, was conducted from March 15 to March 17, 2010. This comprehensive pre-approval and Good Manufacturing Practice (GMP) inspection was performed in accordance with FDA compliance programs for drug process inspections, specifically targeting API manufacturing and pre-approval assessments, utilizing ICH Q7A guidelines as a guide. The inspection covered various systems including Quality, Production, Facilities & Equipment, Materials, Packaging & Labeling, and Laboratory operations.

The inspection resulted in two observations documented on Form FDA 483. The first deficiency noted inadequate corrective actions for a previously identified process deviation. The second observation concerned incomplete information within the company's reprocessing Standard Operating Procedure (SOP). Company management acknowledged these findings, agreeing to implement prompt corrections. The FDA classified this inspection as "Voluntary Action Indicated" (VAI), signifying that although objectionable conditions were found, they do not warrant immediate administrative or regulatory action. A re-inspection is scheduled for March 2012 to verify the adequacy of the implemented corrective actions.