FDA 483 - Sicor de Mexico S.A. de C.V. - December 05, 2023

Sicor de Mexico S.A de C.V., an API manufacturer in Lerma, Mexico, was cited for significant deficiencies across its quality control and manufacturing processes. The inspection revealed failures in thoroughly investigating out-of-specification results, ineffective procedures for preventing objectionable microorganisms in drug substances, and inadequate documentation for sampling activities. Additionally, the firm lacked proper monitoring for endotoxins in non-sterile APIs, had insufficient acceptance criteria for API testing, and failed to validate cleaning procedures for non-dedicated equipment.