FDA 483 - BASF Corporation - July 22, 2024

An FDA inspection of BASF Corporation in Geismar, LA, an API manufacturer, revealed an observation regarding inadequate investigations. The firm failed to adequately investigate out-of-specification (OOS) iodine occurrences for its active pharmaceutical ingredient (API) PVP-Iodine. These investigations did not address the root cause or evaluate the impact on process controls.