FDA 483 - Veranova LP - March 08, 2019

The FDA inspection of Johnson Matthey Inc. in West Deptford, NJ, revealed significant deficiencies in equipment maintenance, quality control, and laboratory practices. Issues included a vacuum seal failure leading to product contamination, inadequate investigations into discrepancies, and a failure to follow established test procedures and stability programs. These findings indicate a lack of adherence to cGMP requirements, impacting the quality and purity of drug substances.