BASF CorporationJuly 22, 2024

FDA 483 - BASF Corporation - July 22, 2024

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Record Details

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.

Company: BASF Corporation
Inspection Date: July 22, 2024
Product Type: Drugs
Office: New Orleans District Office
Person: Brittny C. Cargo (Medical Officer at FDA)

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ID · 62f464e2-49f9-4484-b12c-1d3b480f7034