483
Reactimex S.A. de C.V.Reactimex S.A. de C.V. – FDA 483, Mar 5, 2020
Record Details
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.
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