FDA 483 - Sicor de Mexico S.A. de C.V. - December 13, 2019

Sicor de Mexico S.A de C.V., an API manufacturer in Lerma, Mexico, was cited for significant data integrity issues in its Quality Control Unit, including failure to investigate out-of-specification (OOS) results and inadequate controls over computerized laboratory systems. Additionally, the firm failed to conduct stability studies in a timely manner and lacked adequate cleaning validation for non-dedicated equipment. These observations indicate a systemic breakdown in quality control and manufacturing practices.