Sicor de Mexico S.A. de C.V. – FDA 483, Dec 5, 2023

Sicor de Mexico S.A de C.V., an API manufacturer in Lerma, Mexico, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results, attributing numerous errors to human or equipment issues without adequate root cause analysis or effective corrective actions. Additionally, the inspection revealed ineffective procedures to prevent objectionable microorganisms, lack of documentation for sampling activities, inadequate endotoxin monitoring for non-sterile APIs intended for sterile products, and unvalidated cleaning procedures for non-dedicated equipment.