Sicor de Mexico S.A. de C.V. – FDA 483, Jun 16, 2026

Sicor de Mexico, S.A. de C.V., an API manufacturer in Mexico, received a Form 483 for significant deficiencies in its quality unit and laboratory controls. The firm distributed APIs to the U.S. market without ensuring they were free from contamination or safety impurities. Additionally, the quality unit failed to conduct thorough investigations into out-of-specification results, compromising product quality assurance.