FDA 483 - Catalent Argentina S.A.I.C. - August 04, 2023

An FDA inspection of Catalent Argentina S.A.I.C. in Buenos Aires, Argentina, revealed significant deficiencies in laboratory controls and facility design. The firm's analytical procedures for drug products were found to be inadequate, lacking proper method transfer verification and stability-indicating studies. Additionally, the facility's areas for preparing different products were not sufficiently separated, creating a risk of contamination and mix-ups.