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

Source: https://www.keypedia.com/records/483/reactimex-sa-de-cv/fbdd4eed-91dc-427c-9c4a-7bdfd372d5db

> FDA 483 for Reactimex S.A. de C.V. on March 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reactimex S.A. de C.V.
- Inspection Date: 2020-03-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/reactimex-sa-de-cv/64312e9e-1f0b-42f7-bc6e-ac95307cf1c9

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1