FDA 483 - BASF Corporation - November 17, 2017

An FDA inspection of BASF Corporation, an OTC drug manufacturer in East Setauket, NY, revealed significant deficiencies in quality control, process validation, laboratory controls, and equipment qualification. The firm failed to thoroughly investigate out-of-specification results, lacked cleaning and process validations, did not support media expiry dates, and had unqualified manufacturing equipment. These issues indicate a lack of robust quality systems for drug product manufacturing.