# FDA 483 - Bayer de Mexico, S.A. de C.V. - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/bayer-de-mexico-sa-de-cv/8d6686bf-90a9-434c-8630-bb08bd31c656

> FDA 483 for Bayer de Mexico, S.A. de C.V. on December 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer de Mexico, S.A. de C.V.
- Inspection Date: 2022-12-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Bayer de Mexico, S.A. de C.V., a drug manufacturer in Lerma, Mexico, was cited for deficiencies related to its quality control unit and reserve sample management. The firm failed to adequately control GxP worksheets and assess product quality impact from deviations. Additionally, the inspection found issues with the annual visual examination, reporting, and secondary review of reserve samples for drug products.

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [investigator](https://www.globalkeysolutions.net/people/maria-estrella/36cf1d7d-41af-4f40-9de4-174a82a31a56)

Company: https://www.globalkeysolutions.net/companies/bayer-de-mexico-sa-de-cv/a77cb751-7bb3-4d42-a593-5aa480b7a32f

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