FDA 483 - Reactimex S.A. de C.V. - March 05, 2020

Reactimex S.A. de C.V. in Monterrey, Mexico, a human drug manufacturer, was cited for deficiencies in its computerized systems and analytical procedures. The inspection revealed a lack of controls for chromatography software, including no user authentication or audit trails. Additionally, the firm's analytical procedure for API sampling and assay was found to be insufficiently detailed.