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

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.