Nortec Quimica SA – FDA 483, Aug 4, 2023

During an FDA inspection, Nortec Quimica, S.A., an Active Pharmaceutical Ingredient (API) manufacturer in Duque de Caxias, Brazil, was cited for a significant deficiency in its cleaning validation program. The firm's cleaning validation report was not representative of current equipment usage, specifically failing to account for changes in the worst-case scenario active pharmaceutical ingredient. This issue could impact the quality and safety of APIs manufactured for the U.S. market.